Pfizer

Vaccine was administered at 12:15 pm on 12/29/2020. I continued to work the remainder of the day. I began to feel fatigue around 7 pm that afternoon and fell asleep. When I woke up at midnight on 12/30/20 I noticed numbness beginning in my left foot and spreading into my face over a course of 30 minutes. I never noted any muscle weakness, but felt a tingling sensation on the left side of my body. Then I began to experience chills and sweating. I was able to return to sleep around 2 AM. When I woke up at 5:30 the numbness had resolved.

On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outside of my car for around 15 minutes during a temperature of about 50 degrees. I realized when sharp pain was felt at the digit. After about 5 minutes the digit felt numb. I got in my car, turned on the heater, and massaged my finger. Sharp pain was felt again as circulation returned to the digit. The event last approximately 10 minutes from the moment I realized the finger was pale until color returned. This occurred again on 12/27 at around 2 PM as I walked from my car into a store at a temperature of about 40 degrees. This time, discoloration occurred bilaterally on my left 3rd, 4th, and 5th digits and my right 2nd, 3rd, 4th, and 5th digits. The event lasted more than 15 minutes with constant massaging. This has occurred two more times since then, both times occurring bilaterally with minimal exposure to cold.

Upon immediate injection, reports joint pain on inner left wrist and left thumb. Day 2- present, experiencing increased joint pain on left wrist and thumb as well as swelling at base of thumb and inability to move, pinch, grab, stretch left hand. Occasionally pain spread up left forearm to elbow.

increased (rapid) heartrate at rest, an hour following administration of vaccine. Symptom persisted for half an hour, followed by flushing of the face and slight nausea.

Arm tenderness; This is a spontaneous report from a non-contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on the right arm on 28Dec2020 16:00 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced arm tenderness on 28Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

The night after the covid vaccine, the patient started experiencing left-side facial numbness and tingling of the V2 and V3. Patient also started experiencing ear pain. Patient also had uncontrollable drooling and dry eye. The next day, the patient went to work and there the adverse events started worsening. Patient went to the ER and did a full workup. CT scan to rule out stroke and full blood work. As per the neurologist (MD), patient is developing mild Bell's Palsy. No course of treatment was given.

mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; This is a spontaneous report from a contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), intramuscular on the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 11:00, the patient experienced mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with ibuprofen. Clinical outcome of the events was recovered on an unspecified date in Dec2020. No follow-up attempts are possible. No further information is expected.

-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs -General fatigue All symptoms subsided after 48 hrs

Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration

Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitations.

12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.

I experienced side effects from the COVID vaccine, including notable fatigue, chills/shaking, body aches for approximately 2 days. The third day I woke up without any symptoms.

patient received vaccine 0818, in observation area 08:30 reported that she felt cold, sweaty palms and decreased sensation in hands, ate yogurt 2 hours prior to vaccine 08:32 bp: 124/85, o2sat 99%, hr 94, drinking pepsi, ate peanut butter crackers and granola bar 08:40 patient reports palms less sweaty, bp 141/63, hr 90, 1 glucose tablets administered 08:50 glucometer 130, bp 130/65, hr 83 9:10 T 98.0 oral, bp 125/78, hr 83, patient reports hands no longer cold, palms not sweaty, sensation normal in hands 9:22 patient left to go home, states she felt normal

24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in my injection arm and my armpit lymph nodes were swollen. I treated the pain with Advil and a heating pad. 72 hours after the vaccine I felt faint, dizzy, and nauseous. I began to vomit and have diarrhea that entire night and next morning. I felt very weak and was unable to keep any foods or liquids down. I was unable to walk around. I took Zofran 8mg which helped with the severe nausea and weakness. These symptoms are ongoing.

About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, fever, severe muscle soreness, active loss of smell and taste. General malaise and weakness.

Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, chills when cold, extreme fatigue and weariness. As of the writing of this form, I am still experiencing some lightheadedness, and this morning, I felt very warm, but I overall feel much better.

Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet and knee area. Patient got CBC and went to PCP. CBC was normal except platelets low-normal 150,000. No itching, swelling, etc. This occurred about 9 days after vaccination. Improved gradually and mostly normalized 3 weeks out when receiving 2nd dose of vaccine. No other symptoms reported besides sore arm for 2 days.

Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursday 12/31- some pain/soreness in arms and legs; no HA Friday 1/1- pain worse (7 out of 10); temp 99.8; Sat 1/2 cough in the morning, soreness; in the evening pain worse; cough resolved; Sunday 1/3 extreme pain 10 out of 10; presented to the ED; prescribed Toradol and excedrin Numbness and pain in upper and lower extremities, particularly in R arm; 10 out of 10 pain; 101.0 temperature Monday 1/4 temperature down to 99.5 this am (has been taking Tylenol); still experience significant pain Headache that she describes as migraine worsens with standing up, walking, talking Pain in legs, if stands for more than 10 seconds she experiences extreme pain Denies SOB, wheezing, coughing The ED advised her to take Toradol for 48 hours and contact a PCP for follow up.

mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower legs evening of vaccine; Felt mild headache; foggy feeling this night; This is a spontaneous report from a contactable healthcare professional, reporting for a patient. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231), intramuscular in the right arm on 30Dec2020 at 09:45 (at the age of 26-years-old) as a single dose for Covid-19 vaccination. Medical history included Covid-19 prior to the vaccination on an unknown date. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On 30Dec2020 at 19:30, the patient experienced diffuse myalgias, more severe on both right and left arm and numbness in lower legs the evening of the vaccine; felt mild headache and foggy feeling that night as well. The second day on 31Dec2020, the patient experienced mild flu-like symptoms such as weakness, fatigue, and myalgias. Therapeutic measures were taken for the myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness which included Tylenol. The clinical outcome of the events myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness was recovered on an unknown date.

Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache

Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.

Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was not bothersome so I proceeded to go home. At 2:04 pm, approximately 40 minutes after vaccination was driving home and began to experience an elevated HR, shortness of breath/difficulty breathing and throat tightness. Proceeded to pull over to a gas station and felt extremely weak when trying to walk and a tingling sensation all over. Took 25 mg of Benadryl tablets and symptoms began to subside within about 10 minutes or so. Proceeded to continue driving home and had another episode at 2:49 pm, experienced significant shortness of breath and tingling sensation in mouth spread to back of tongue and it felt swollen. I bought liquid Benadryl instead and took ~20 mL. This episode resolved within 10-20 minutes as well and was okay for the rest of the evening.

Extreme soreness in arm that night but especially next day Headache/ borderline migraine next day and continuing for about a week and a half (so far) Mild body aches/ malaise the day after Fatigue next day and for next week and a half (so far) afterwards

Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.

Numbness and tingling bil upper extremities, seizure, temporary paralysis R arm. Started day after vaccine given, was observed overnight in hospital.

Pt reported shortly after receiving her vaccine that she had tingling feeling on the top of her head, bilateral wrists, mid back, and right lower extremity. This was coming and going and had not happened the last about 10 minutes she was in the clinic.

Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right ear feeling blocked 2 weeks post vaccine; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 at a single dose for covid-19 vaccination. Medical history included migraine. The patient has no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received her most recent COVID-19 vaccine in a hospital. The patient had right sided face numb/tingling with no drooping or asymmetry and right ear feeling blocked 2 weeks post vaccine (30Dec2020). The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the adverse event. The adverse event result in emergency room/department or urgent care. The event was considered as non-serious. The outcome of the events was recovering.

Sore arm low grade fever chills body aches fatigue headache lymph node tenderness on the right side arm pit

chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fatigue

Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.

Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching

first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like nerve pain from my armpit to my fingers (left arm).; my lymph node in my left armpit is swollen because it feels like theres a golf ball pushing; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: el1284), intramuscular on 05Jan2021 at 15:30 at single dose in left arm for covid-19 immunization. Medical history included tachycardia, IBS (Irritable bowel syndrome), and allergies: Sulfa drugs. Concomitant medication included nortriptyline, buspirone, lubiprostone (AMITIZA), probiotics, diltiazem. The patient previously received the first dose bnt162b2 (batch/lot number: eh9899) in left arm on 18Dec2020 for covid-19 immunization. The patient reported that her injection arm was hurting a lot. It felt like nerve pain from her armpit to her fingers (left arm). She believed her lymph node in her left armpit was swollen because it felt like there's a golf ball pushing into her armpit. These events happened on 06Jan2021 at 01:00. These events were reported as non-serious by reporter. The patient did not receive treatment for these events. The outcome of these events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.

About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - Body aches - Joint aches - Headache About 40 hours after time of vaccine: - Fainting spells x2 (shakiness, blurry vision, ringing in ears, loss of balance)

Neck and facial hives with swelling. Face was red and hot to tough. Benadryl taken-symptoms resolved by am

Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.

12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described as a nerve and muscle ache/throb, or "growing pains"/RLS symptoms. Put on compression socks which helped, but still too uncomfortable to sleep. Was able to sleep after taking ibuprofen 800mg and drinking water. 6 hours after the ibuprofen was administered, pain returned in lower legs as well as neck/ears with body temperature swings (cold, teeth chattering to sweating uncontrollably in a few minutes). After 1 hour of trying to sleep but failing, put compression socks back on. Temperature rose to 100-100.2 F, chills causing whole body to shake under multiple blankets. Tingling/muscle pains extremely uncomfortable and unable to rest, took another ibuprofen 800mg and water and was able to sleep. Tingling and muscle pains have continued as soon as ibuprofen wears off and come back more intense each time, most notably in the lower legs and near ears/neck and elbow of arm administered in (similar to "tennis elbow," assumed to be provoked by inflammation, happened with first dose).

I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart rate went up to 124 beats per minute. I was having flushing, tingling through my whole body. My blood pressure went up to 139/96. I was having itching and blotchiness on my chest, neck, left arm and thighs.This lasted for 3 hours with my heart rate going up and down. I was sent to the ER by the nurses who gave my vaccine. There they gave me Benadryl. 2 tablets of 25mg each. This helped and I was sent home.

Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vaccine on 1/10/2021 at 11:30 AM. She received the Pfizer vaccine. She works at a nursing home. She had some fatigue and tiredness during the day but woke up on the second day without any symptoms. On 1/30/2021, she developed bilateral eyelid swelling. The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus. The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising. She denies any hives anywhere else. She does not have a large local reaction at the injection site. She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis. She used Benadryl with significant improvement. She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation. The reaction lasted for 1 week. She received her influenza vaccination in October 20, 2020. She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool. She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction. She has not had this reaction for more than 6 years.

severely sore arm; injured a ligament in the shoulder; Unable to lift arm; pain in shoulder and muscle; pain in shoulder and muscle; This is a spontaneous report from a contactable other healthcare professional (hcp). A 26-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date not reported), intramuscular on 07Jan2021 08:45 at a single dose in the left arm for COVID-19 immunization. Medical history included allergic to tree nuts and patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medication included tetanus vaccine on 02Jan2021 at a single dose. The patient had no other medications in two weeks. On 10Jan2021, the patient experienced severely sore arm as well as feeling as though patient injured a ligament in the shoulder. The patient was unable to lift arm without pain in shoulder and muscle. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Treatments was not received in response to the events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events severely sore arm, injured a ligament in the shoulder, unable to lift arm, and pain in shoulder and muscle. Information on the lot/batch number has been requested.

Burning when it went in, tingling left arm down to hand, left left foot. Feels like it's getting worse. Advised to see PCP.

Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Approximately 4 days after my second dose of Pfizer vaccine, I started noticing my left eye being swollen and constantly watering. 7 days post vaccine, I started having left sided facial weakness and droop. I was diagnosed with Bell's palsy by my Primary Care Physician today (8 days post vaccine).

I woke up at 3:10am and had severe chills and a fever of 102°F. My fever didn?t go down to 99° until 11 hours later. The following day I was really shaky and dizzy. I had to take off two days from work then went to work on Friday and was weak and exhausted all day.

New onset peripheral neuropathy evening after shot, felt like a deep burn that started mid shin to toes, not radiculopathy. Constant for 3 days, worse in the evenings. Associated with mild frontal bilateral HA and a few occurrences of fleeting fasciculation of R lip and R paraspinal muscles. Symptoms complete resolved after 1 week.

The patient experienced itching after the first dose of the COVID-19 vaccine. Pre-medicated with diphenhydramine prior to the 2nd dose of the OVID-19 vaccine. 9 minutes after the vaccination, the patient felt itchy, flushed and received oral dexamethasone. [atient was sent out with oral dexamethasone home.

generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID. The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.

Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse. A 26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.

Hives noted the following morning that were described as red, hot and itchy. Located on chest, head, hands and arms, side of right hip. Used Claritin and ice packs with some relief. Also experienced numbness on her left shoulder and left chest to navel which subsided by mid day. No breathing issues or any additional signs or symptoms.

I experienced chest pain or discomfort intermittently mid-day and afternoon. It subsided after this point. The night of 1/13/21, I fell asleep but awoke multiple times cold. I experienced the chills through about midnight. The next morning, 1/14/21, I woke up with a headache at about 5:30am. I took a dose of Aleve and the symptoms had subsided by about 6:30am

My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.

Numbness and tingling of bilateral feet and lower legs started about 30 minutes after receiving vaccine. Numbness and tingling has been continuous for 30 hours and counting. Was told by nurse practitioner that this could be the start of Guillain-Barré syndrome.

Pfizer Covid Vaccine; 26 y.o. female who presents after feeling weak and dizzy after COVID vaccination. Patient received the vaccination at 1230 and is still symptomatic. There is no sign of anaphylaxis. Obtained orthostatics at bedside and she is not orthostatic. Patient appears very anxious. Will give patient juice and crackers as well as obtain a glucose. Gave the option to obtain labs however she declines at this time. Patient was given 216 oz bottles of water and a 12 oz bottle of grape juice and a muffin and also saltines. Patient is now stable for discharge

The first side effect appeared around 8:30 pm. I felt extremely cold and got chills. I put an additional sweater on but the chills increases. I developed a fever by 10 pm. My entire body started shivering by 11:30 pm and I was feeling extremely cold. Additionally, I had extreme body and joint pain. The joint pain were especially in me knees, elbows, and my back. I felt sick to my stomach but did not vomit. The next day (Jan 20) I still had extreme body and joint pain, a strong migraine, fever, and felt very fatigue.

26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states she received her vaccine at 3pm, approx 1-2 hrs later started to notice left sided lip numbness that radiated to her left ear and left side of head. No difficulty speaking, no facial heaviness, no changes in vision or hearing. No n/v, no fevers. No previous similar episodes. ED states low suspicion for any stroke, states may be an early bell's palsy vs a pre-rash zoster. Unlikely to be reaction to vaccine. Some slight improvement during ED stay.

3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous symptoms + headache (5 out of 10) and cold sweats 8 hours following vaccine: previous symptoms + widespread body aches (6 out of 10) Restless sleep punctuated by waking up with cold sweats or overheating. 24 hours following vaccine: previous symptoms persist. Headache and body aches have worsened in severity. Unable to work for the morning but was able to go in the afternoon for a short time period. Lower body aches are particularly severe. Fatigue is noticeable. Mental health conditions have worsened but that may be due to lack of sleep. 30 hours following the vaccine: chills, nausea, and dizziness have dissipated completely. They were slowly improving throughout the day. Body aches and headache still severe but lessened with marijuana use. 48 hours following the vaccine: all symptom seemed to have subsided during the night. Sleep was much better quality. Only remaining symptom is an ache on the right side of my chest towards my ribs.

First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated with numbness and weakness of the Left Arm, Left Leg, Left side of the face.

Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 hour later while the charge was eating lunch on plaza and c/o of face swelling/feeling flushed. RN walked patient to ER. In the ED, pt reports bilateral eye swelling, facial redness, scratchy throat. Pt initially felt SOB but breathing ok now. No tongue swelling.

Within five minutes I felt very faint and dizzy along with nausea. Then came the shortness of breath and the feeling of pins and needles which also brought itching and some minor hives with it. The dizziness, nausea, and feeling of fainting went away after about 10 minutes and I had to go to the Emergency Department to take care of the shortness of breath and hive like reaction. I was given some medications and they diagnosed it as a moderate allergic reaction to the vaccine. I was completely fine with the first one.

Within minutes of injection dizziness, increased heartrate, increased blood pressure, flushed color, feeling of weakness in limbs, and shakey hands and feet. This was treated by reclining with feet up, sitting in a dark room, and drinking cold water while monitoring symptoms. Symptoms resolved within minutes. About an hour after injection lethargy, feeling chilled, in particular hands were very cold, mental fog, and slurred speech. This resolved without intervention within a couple of hours.

side effects after 2nd shot only: - fever x4 days (and counting) - body aches x2 days - chills x2 days - sore arm Fever brought down with Tylenol.

Muscle aches, headache, chills, nausea, diarrhea, chills, right arm pain, severe right armpit swelling (lymph node swelling).

Probably 5 minutes after receiving the vaccine I started noticing that my right side of my face was numb. Over time the numbness faded into tingly ness (like after getting a numbing shot at the dentist). It was only the right side of my face and focused around my corner of my mouth and along my jawbone. Over time the feeling subsided probably an hour. While being observed at the clinic they did not notice signs of Bells palsy( facial muscles were still responding symmetrically). Had not sign of allergic reaction at the injection site.

As patient was waiting in waiting area approximately 5 minutes after receiving her 1st COVID vaccine, pt's friend called pharmacist over as patient felt she was about to faint. She had her eyes closed and said she felt faint. Notified incident command to call for provider. We moved her to an exam room so she could lie down. She said she felt warm and dizzy. Pt breathing heavily. Denied chest pain. Had stomach pain and some nausea. Pt was given water. ER provider arrived about 4:30 and listened to lungs, carotids, talked to patient regarding vasovagal reaction. Pt slowly began to feel better and was talking and laughing. Waited with patient until 4:50, able to stand on own, not dizzy anymore, felt okay to leave.

Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.

Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; This is a spontaneous report from a contactable physician (patient). A 26-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), intramuscular (vaccine location: Left arm) on 11Jan2021 09:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient had no medical history. The patient was not pregnant. The patient had no known allergies. The patient's had no concomitant medications. There had been no other vaccine in four weeks. There were no other medications in two weeks. The patient had no prior covid vaccination. The patient experienced fever, chills, night sweats, fatigue, and headache on 11Jan2021 22:00. The patient has not been tested for covid post vaccination. No treatment was provided. The outcome of the events was not recovered. Information on the Batch/Lot number has been requested.

Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at 11:00AM 12Jan2021 at right arm for COVID-19 immunisation. The first dose was received on 23Dec2020 10:30 AM at right arm. The patient had no medical history, no known allergies and had no Covid-19 before vaccination. The patient had not received other medications in two weeks and no vaccine received in four weeks. At 11:15 AM after the second dose, the patient experienced nerve pain from right upper arm to fingers. Pain was with usage of hand and fingers. Patient had not received treatment for the event. The patient had not tested after vaccination. The event was resolving at the time of reporting. The reporter considered that the event was non-serious. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.

Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got really hot while the rest of my body stayed cold. A small headache began to turn into a migraine. During the night, my body began to hurt beyond achy causing me to toss and turn. When I woke up in the morning, I couldn't stand even the littlest of pressure placed on my body. For example, my cat jumped on my leg and it felt like someone wacked me with a baseball bat because of how sensitive my body was. The only treatment used for myself during this time was Tylenol. It helped with the head aches. Overall, it took me about three nights to actually feel ok again.

Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced chills and myalgia through the night. I did not improve when I woke up on 01/25. The chills and myalgia worsened and were complicated by vomiting without blood. I called off sick from work and took 3 Aleve tablets. I went back to sleep with improvement in symptoms approximately 6 hours later, with only mild myalgias and a very sore L. arm. Symptoms completely resolved by the morning of 01/26.

Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly on the left arm on 04Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included liver failure, mononucleosis, gallbladder disease, mitral regurgitation of the heart and fibromyalgia; patient had no known allergies. Concomitant medications were not reported. Patient did not have COVID prior vaccination, no other vaccine was given in four weeks prior and patient did not receive other medications within two weeks of the vaccine. The vaccine was given at a nursing home/senior living facility. On 04Jan2021, the patient experienced fever, cold chills, hot flashes, nausea, headache and increased body pain. Moderate side effects were also reported from 05Jan2021 to 09Jan2021. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 04Jan2021 and saliva swab test for COVID: pending result on 11Jan2021. Outcome of the events was recovering. Information on the lot/ batch number has been requested.

G2P0, 5w5d; The patient is calling with vaginal bleeding in pregnancy. Calling with c/o dizziness with headache; Has a history of migraines; States she has subclinical hypothyroidism. Has tried Tylenol 500 mg for headache that worked for a little while; She denies vomiting, but does have nausea; Will try to increase water and protein intake; Will let us know if she gets worse/vision changes and will check in with PCP as they wanted to do a VV if dizziness got worse. Bleeding continued into following day. Documented as likely / threatened miscarriage.

Reported dizziness, cold extremities, redness in left ear and rash on left shoulder noted. Mild anxiety. 25 mg Benadryl po administered. Returned to work at 10:25 am. No reaction to first dose reported.

After receiving the second dose of the covid 19 vaccine, as I was walking to the elevator, my vision started to become blurred and I began to see stars. I walked over to a nearby chair and as I sat down it felt as if my throat was closing. I began sweating profusely and my whole body was flushed. My heart rate was tachycardic and my blood pressure was hypertensive when checked in the ED. When I got to the ED, my vitals were obtained like I described but my heart rate had slowed down by time I got there. A nurse passing by explained that my heart was tachycardia when he assessed me in the chair. The ED did an EKG of my heart that determined my heart rate was normal sinus rhythm in the 70s. They observed me for roughly an hour and let me go home. My discharge papers explain I had a vagal response.

I had a very sore arm which is normal, however the day after I received the vaccine I was extremely nauseous and I threw up 5x at 7:30 AM. I had a migraine the rest of the day and was extremely tired, sleeping a total of 19 hours.

Symptoms from the Pfizer vaccine has been numb like feeling in the face, arms, legs, and hands. These symtoms arised Saturday Jan. 23, 2021 (a day after vaccine). Within the next couple of days, symtoms were still present, and presented more frequently throughout the days. Occuring more than 4 times a day.

syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation. Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility. No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Arm soreness that evening and the next morning. Later in the afternoon the next day, my other arm felt sore and was aching. 2 days later, I developed a sore throat and general malaise.

Immediately after vaccine administration, Patient reported feeling warm and requested for a chair to elevate her legs. Patient was provided with a chair and elevated her legs with assistance. While elevating legs, patient began leaning to the side and sliding down in the chair. RN held patient to prevent a fall and called for help. We tried communicating with patient but she only produced humming sounds. Approximately 10 seconds later patient verbalized her name upon questioning. Patient reported later that she "blacked out" while her eyes were open. Patient verbalized that she has a history of sweating and vaso-vagal response to blood draws and vaccine administrations.

Pfizer-BioNTech COVID-19 Vaccine 17 hours post-vaccine: a brief moment of dizziness before waking and weakness upon waking but subsiding immediately. Upon waking: left sided neck pain, and left sided chest pain aggravated only by extending left arm forward. 24 hours post-vaccine: fatigue and brain foggyness 30 hours post-vaccine: aforementioned joint pain relieves 48 hours post-vaccine: relief of most symptoms

anxiety/possible panic attack, left arm numbness/tingling, patient encouraged to go to ER for further eval, facility staff took her to ER (next door to facility).

chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on her left arm, via an unspecified route of administration on 13Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Asthma and GERD. Concomitant medication included baclofen, buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL). The patient previously took protonix, reglan and ambien; experienced allergies with all. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Dec2020 (first dose). The patient experienced chills, body aches, fever up to 103.8, headache, weakness and malaise; all on 13Jan2021 23:00. No treatment has been received for the events. The outcome of the events was not recovered.

severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.

Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)

Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration: 30Apr2021), via injection in left upper arm on 13Jan2021 at 15:00 at a single dose for vaccination. Medical history and concomitant medication reported as none. No family medical history. The patient received her first dose of COVID-19 vaccine via injection to left upper arm on 23Dec2020 at around 1:00pm-2:00pm (Lot: EK5730, Expiry: 31Mar2021, NDC: 59267-1000-2). The patient received her second dose of COVID-19 vaccine on 13Jan2021 in a public health department. She called to report the side effects she experienced since about 06:30 AM on 14Jan2021 which includes chills, fever, hot flashes, body aches, and having a lot of fatigue. She was sent home from work on 14Jan2021 related to the reported adverse events. Chills continued through most of the night from 14Jan2021 to 15Jan2021. On 14Jan2021, she had fever of 102 degrees Fahrenheit that was ongoing throughout most of days. The patient is now feeling fine, all events have improved. She used ice packs for the adverse events and had taken Tylenol 2 rounds of 500mg strength products for total of about 2000mg throughout 14Jan2021 to 15Jan2021. The patient confirmed that there were no concomitant products or other medical conditions to report and has no existing medical condition. She verified that she has had no testing/investigations/lab work/imaging/diagnostic work done relative to the report. No additional vaccines administered on same date of the vaccine. The patient did not require emergency room/physician's office visit. The patient has no prior vaccinations within 4 weeks. The patient did not have adverse event prior vaccinations. No relevant test done. The patient was recovering from the events. The events chills, fever, hot flashes, body aches, fatigue were assessed as related by primary source reporter.

Had a cold sweat; Rapid heartrate; Went to ER on Jan 2 - decreased magnesium; IV therapy - magnesium infusion (January 2st) - ER - Put me on a magnesium supplement; the symptoms resolved a few days later; Saw Dr on January 5th After 2nd dose of - had rapid heartrate for second dose but it was only periodically for two days and I didn't seek medical care

I received Botox injections on 1/21/21 to both jaw muscles. On the evening of 1/29/21, the left side of my face became swollen and felt tingly, numb, and painful. My lips also became swollen when I woke up the morning of 1/30/21.

Pfizer COVID- 19 Vaccine Pt received Pfizer COVID vaccine lot #EL3249. Pt sat for about 10 minutes, arm became itchy, gave diphenhydramine x 1 dose. Pt continued to sit for assessment for another 15 min. Pt stated she felt hot, but is typical for her to feel warm. No chest pain, SOB, blurred vision. Pt cleared to leave facility.

Arm pain, left leg pain, back pain, neck pain, shooting pain on side, chest pain when breathing, fever, headache

Fever; chills; headache; myalgia; fatigue; sore arm; This is a spontaneous report from a Non-contactable Consumer (Patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at Left arm on 17Jan2021 14:00 at single dose for covid-19 immunization. Patient was not pregnant. Medical history included COVID-19 prior vaccination. The COVID-19 vaccine was administered at Hospital. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's received the first dose of BNT162B2 on 26Dec2020 at left arm for covid-19 immunization. The patient experienced Fever, chills, headache, myalgia, fatigue, sore arm on 17Jan2021 23:00. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Jan2021. No treatment received for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

I experienced sweating, chills, fatigue and sore at the injection sight. I was sore at the injection site right after it was administered. I then experienced severe chills in the evening, starting at about 7pm. The next morning I woke up fatigued and alternated between sweating and having the chills and shaking.

Slight body aches the day after, getting more prominent by 3:00 and worse in the evening. Pain was both widespread and often sharp. Bad continual leg pain late evening and bedtime. Was able to fall asleep without too much trouble and pain was gone by morning. Did not take Advil or other pain relief medication.

Got second dose COVID-19 vaccine 1/29/2021, and it looked like it was given very high and she immediately had pain and discomfort. 2 hours later she had excruciating pain in her shoulder and had difficulty moving the shoulder. She is taking ibuprofen and it better. She still has pain and has occasionally shooting pains. She can move it normally now however and began taking ibuprofen prn

Muscle aches, weakness, fever, chills, slightly swollen face and lymph nodes, injection site pain, feeling unwell, fatigue.

sore arm; joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pai; body aches all over; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140, expiration date was not reported), intramuscular in left arm on 18Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included headaches of an unknown origin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant. She did no receive any other vaccine four weeks prior covid vaccine. She did not have covid prior to vaccination. She was not tested for covid post vaccination. She had no known allergies. The patient reported adverse events for the first shot: Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain; and body aches all over for the next 2 days. The events' onset was on 18Dec2020 at 07:00 PM. Outcome recovered for events 'Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain' was recovered in Dec2020, while body aches all over was recovered on 20Dec2020.No treatment received for the events.

About 2 minutes after injection, I had a sudden rush of warmth throughout my body starting in my abdomen then causing my pulse to feel like it was pounding out of my neck. Got light headed. EMS came and my blood pressure raised to 155/95 and my pulse was up in the 150s and I was shaking. Started to go down but felt crappy for over 2 hours. Happened again 30seconds after the second injection. Pulse up to almost 160. 02 stats stayed normal. Post first injection had sore arm and lots of fatigue and brain fog. Following the second injection 12 hours post started having nausea, and diarrhea. Continued to have joint pain, muscle aches, headaches for days, and my lymph nodes swelled up and were extremely painful.

Employee got 2nd dose of pfizer vaccine on 1/12/21 and on 1/13/21 she started having tachycardia resting 120, walking 150. she did not have this at the time of her first dose. She also feels warm, chills and fatigue but those are improving. She was urged to go to urgent care to get evaluated.

I am a pharmacist for pharmacy and received my first dose of Pfizer Covid-19 vaccine while at work by another pharmacist. Vaccine given around 2:15 PM on 2/2/21 Less than 5 minutes after vaccine - arm tingling at site of injection, arm tingling spread from injection site to fingers, tingling and pins/needles traveled through underarm area and moved across left side of chest, slight chest pain on left side, whole body started tingling, dizziness, racing heart. While experiencing all of these symptoms, I sat on the ground, took two tablets of 25mg Benadryl, drank water, and tried to breath steady to make dizziness go away. Working in this healthcare setting, I was aware I was having an adverse reaction to the vaccine and was prepared with an epi-pen in case of any severe anaphylaxis shock - I did NOT have to use the epi-pen. Less than 15 minutes after vaccine - the chest pain, arm pins/needles stopped, I felt lightheaded still, another co-worker checked my blood pressure which had risen to 178/120 and pulse of 120. About 1 hour after vaccine - still felt light headed, blood pressure still elevated at 158/107, pulse of 107. Around 5:45 PM - After consulting personal friend physicians, I was instructed to go to ER and have an EKG of my heart since my blood pressure and pulse had spiked so high and suddenly. I was able to find coverage at work so that I could leave my shift and get a ride to the emergency room. After 6 PM (admitted into ER) - upon admission blood pressure of 176/117 and pulse of 113

Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for 24 hours. I did not seek treatment but I will be letting my OBGYN know at the next appointment.

Headache; severe chills; severe shivering/shakes; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), intramuscularly in the left arm, on 21Jan2021 10:30 (at the age of 26-years-old) at a single dose for COVID-19 immunization. Medical history included latex allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included ethinylestradiol, etynodiol diacetate (KELNOR) taken as a contraceptive and fexofenadine hydrochloride (ALLEGRA). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0142), intramuscularly in the left arm, on 31Dec2020 at 17:00 (at the age of 26-years-old) for COVID-19 immunization. The patient experienced headache, severe chills, and severe shivering/shakes on 21Jan2021 at 21:00. The events were reported as non-serious. The clinical course was reported as follows: Less than 12 hours after getting vaccinated, the patient experienced headache, severe chills, severe shivering/shakes that didn't stop. Being under blankets didn't help but using heating pad helped a lot. The shaking stopped the next morning, but patient still had a bit of chills and headache the next day. Therapeutic measures were taken as a result of the severe chills and severe shivering/shakes as aforementioned. The patient did not receive any treatment for headache as reported. The clinical outcome of headache and chill was recovering and of severe shivering/shakes was recovered on 22Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Hot flashes; chills; This is a spontaneous report received from a non-contactable Nurse. A 26-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231 and Expiration date was unspecified) on 30Dec2020 14:00 as single dose, (at 26 years of age), intramuscular left arm for COVID-19 immunisation. Medical history included allergic to shellfish. Concomitant medication was none. The Patient is not pregnant. The patient did not have Covid prior to vaccination. The patient was not tested post vaccination for Covid. No other vaccine was taken within four weeks. The patient did not have treatment. The patient experienced Hot flashes and chills 24hrs after receiving vaccine (31Dec2020 16:00). Outcome of event Hot flashes was recovered and chills was recovered. No follow-up attempts are possible. No further information expected.

Numbness and tingling in both feet and lower extremities; Numbness and tingling in both feet and lower extremities; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 26-years-old female patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3302, via an unspecified route of administration in right arm on 19Jan2021 at 17:30, at 26 years of age, at single dose for COVID-19 immunization as she was a front line worker. The vaccine was administered at the facility where the patient works. The patient had no relevant medical history and no concomitant medications. On 19Jan2021, about 20 minutes after receiving the vaccine dose (also reported at 18:00) she started having nonstop numbness and tingling in both feet and lower extremities, which has been going on for 46 hours straight. The events were assessed as medically significant, although a visit to emergency room or physician office was not required. The nurse reported that a doctor mentioned Guillain-Barre Syndrome which can lead to progressive muscle weakness and damaged nerves and she is severely concerned, although she has no health history. At the time of the report the reported events had not recovered yet. The reporter assessed the event related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Method of assessment: Global Introspection).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient presented to emergency department at Hospital on 2/03/21 with chief complaint of numbness and tingling over entire left side of body with pain level 9 out of 10. Patient reported that she received first dose of COVID vaccine on 1/25/21. On 1/31/21 numbness began in left lower extremity and progressed to left upper extremity over course of several days. Patient was afebrile, alert and ortiented. Circulation, range of motion and sensation intact. Lumbar puncture performed and appeared normal. Fentanyl 50mg IVP, Zofran 4mg IVP administerd and symptoms improved. Patient discharged home per doctor. Prescription provided for gabapentin 300mg 3 times daily. Follow up with PCP in 2-3 days recommended

Left side Swollen Lymph nodes was reported as worsned.; Left Forearm hurting and swelling; forearm hurts super bad; the lymph nodes were really tender, she would push it and it would hurt; lymph nodes on her arms got swollen to softball size/ Left side Swollen Lymph nodes/ the lymph nodes getting bigger; This is a spontaneous report from a contactable consumer reporting for herself. A 26-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 19Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included etonogestrel (NEXPLANON) for contraceptive implant. The patient received the first dose of BNT162B2 on 29Dec2020. The patient reported a side effect from receiving the vaccine, lymph nodes on her arms got swollen to "softball size" since 19Jan2021 when she received the second dose of the vaccine and wants to know if this was normal. She understands that the arm was going to hurt, but she was noticing that her forearm hurts super bad and it a bit swollen, just on the side of the forearm its swollen, but under that arm her lymph nodes are swollen, she can barely pick up the arm and it just hurts on 20Jan2021. She noticed yesterday (19Jan2021), the lymph nodes were really tender, she would push it and it would hurt. Then when she got home from work, she lifted the arm to look at it, and she could see the swollen lymph nodes, the longer she kept the arm up, she could see the lymph nodes getting bigger. She wants to know how long this will last. She was talking to her mom and she was freaking out saying that people are dying from covid and the swollen lymph nodes, and that's why she has called today. She also stated that her left side swollen lymph nodes was worsened on an unspecified date. The outcome of the event swollen lymph nodes was not recovered, left forearm hurting and swelling and forearm hurts super bad was recovering while other events were unknown. Information on the Lot/Batch number has been requested.

Sore arm a few hours after getting the shot Next morning, sore arm, very sensitive skin, temperature of 99.7

The vaccine was inadequately administered, too deep and too high, into the shoulder bursa. The patient developed sharp pain soon after which persisted for two days. Soon after she started with neurological symptoms including increased sweating in the affected arm, pain in the branchial plexus region, including arm and forearm, paresthesias in arm, forearm, and fingers, sensation of scapula being dislocated, and tightening sensation in the lateral aspect of the chest. Symptoms are worsening every day. There is a high suspicion that she is developing Parsonage-Turner syndrome.

Sharp left arm pain from fingertips to neck. Most significant pain in medial arm above elbow with radiating pain to pinky and ring finger to the shoulder and neck. Pain lasted 5+ days (pain worsened until day 3 and began to diminish on day 4). Also experienced body aches and tiredness on day after vaccine was administered.

Late Saturday (02/06/2021) night /early Sunday (02/07/2021) morning I noticed a lump on my chest near my left collar bone (received both doses in my left arm). It is noticeably sore and tender to touch

Pfizer-BioNTech COVID-19 Vaccine EUA -increasingly sore arm starting about three hours after injection -fatigue, body aches, headaches starting around 10pm the night of the injection

mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of words; felt very cold; tingling around the mouth; aura like a bad migraine; bright spotty vision in the peripheral right field; bright spotty vision in the peripheral right field; thought she was having a stroke; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; likely a severe migraine; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date was unknown), intramuscularly on the left arm on 30Dec2020 at 14:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history included COVID-19, which was diagnosed prior to vaccination and migraines (before). The patient had no allergies to medications, food, or other products. Concomitant medication included melatonin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 15:45 or 1 hour after the vaccine injection, the patient had an aura like a bad migraine and she had bright spotty vision in the peripheral right field for 15-20 minutes; the patient has had migraines before, but they're not common for her. Two hours after the vaccine, on 30Dec2020 at 16:45, the patient had mental confusion and an inability to speak; she tried to say things to her husband and it was a jumbled, meaningless string of words. She also felt very cold and she had tingling around the mouth. Her husband thought she was having a stroke and called 911 on 30Dec2020. All her vitals were stable, and within 10 minutes she could speak again. On 30Dec2020, the patient's electrocardiogram (EKG) showed peaked T waves, common with dehydration and high potassium. She was encouraged to go to the emergency room (ER). Instead of taking the ambulance, she drove herself several hours later. The patient wanted someone to tell her it wasn't a stroke. After a brief neurological exam on 30Dec2020, the doctor said it was likely a severe migraine and wrote the reason for her visit as a vaccine reaction. This took place in the late evening to early morning, and she missed one day of work. The events did result in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from all the events on 31Dec2020.; Sender's Comments: Based on the close temporal relationship, the association between the event stroke with BNt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

1st dose vaccine 1/21/21; developed nausea, weakness, vomiting, diarrhea, and chills on 2/4/21; seen at ICC 2/5/21.

Complex Migraine and triggered trigeminal neuralgia event.; Complex Migraine and triggered trigeminal neuralgia event.; Complex Migraine and triggered trigeminal neuralgia event.; This is a spontaneous report from a contactable other healthcare professional. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el8982; expiry date: unknown) intramuscular in the right arm, on 22Jan2021 at 11:15, at a single dose, for COVID-19 immunisation. Medical history included ongoing trigeminal neuralgia and polycystic ovaries (PCOS). The patient had no known allergies. Concomitant medication included gabapentin. The previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ek9231) intramuscular in the left arm, on 31Dec2020 at 10:30 AM for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 23Jan2021 at 09:30, the patient experienced complex migraine and triggered trigeminal neuralgia event. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.

My radial nerve was hit during the injection and I have had little to no feeling in my left pinky finger since receiving the shot.

After the first vaccine, I had a severe migraine for over 48 hours. I had to contact my neurologist for rescue medication. After the second dose, I had chills, sweats, body aches, migraines, nausea, and dizziness for 24 hours.

When pt was administered the 1st dose several hours later pt was seen in the ED for bells palsy symptoms, made aware about symptoms returning for the second dose, cleared by personal physician and neurologist.

The following day, 02/07/2021 around 3:30pm I started feeling extreme fatigue, mild sore throat and chills. The following days after I was okay, with a sore throat only occurring in the evening after 4pm, along with vertigo and slight disorientation for approximately 8 days. Starting Saturday, 02/13 around 8pm I noticed a tingling sensation in my right middle finger, that continued to Sunday and through to today. As of this morning, 02/15, I still have the nerve pain in my finger that is now spreading to the palm of my hand.

Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On 02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

neurological symptoms most consistent with Parsonage-Turner syndrome.; neurological symptoms most consistent with Parsonage-Turner syndrome.; Worsening including increasing pain extending to all the arm; paresthesias throughout arm and hand,; feeling of dislocated scapula; tightening of the lateral aspect of the chest; sharp pain; The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain; This is a spontaneous report from a contactable physician. A 26-year-old female patient (daughter) (not preganent) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3302 and Expiration Date unknown) via Intramuscular on 18Jan2021 (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EH9899 and Expiration Date unknown) via Intramuscular on 30Dec2020 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as none. The concomitant medications were not reported. No other vaccine in four weeks. The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain and started with neurological symptoms most consistent with Parsonage-Turner syndrome, which includes pain in the brachial plexus with weakness, paresthesia which might never resolve. This is an autoimmune disorder. Patient was worsening including increasing pain extending to all the arm, paresthesias throughout arm and hand, feeling of dislocated scapula, tightening of the lateral aspect of the chest. Onset date for all events was 18Jan2021 and resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with treatment of oral steroids and nonsteroidal anti-inflammatory drugs (NSAID). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the neurological symptoms, Parsonage-Turner syndrome and other reported events in the clinical context of wrong injection technique due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pfizer-BioNTech Covid-19 Vaccine EUA 15 minutes after receiving the vaccine, when I stood to leave the facility, I felt light-headed which went away after a few deep breaths. 20 minutes after receiving the vaccine, having left the facility, my right hand hand had tingling. I took ibuprofen. The tingling lasted until 1:20 P.M. (at least 3 hours from receiving the vaccine).

Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadryl PO. At 7 minutes post vaccination had c/o feeling warm and having a headache. Vitals taken, vitals repeated 5 minutes later, still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back. At 11:15 an additional 25 mg tablet of Benadryl PO was given.

Patient presented for second dose of covid vaccine. She was administered Pfizer vaccine. Patient fainted approximately 1 minute after administration of vaccine. Started as syncopal episode then patient started seizing - tonic/clonic. Patient was still seated in chair and seizing lasted about 1 minutes. 911 called. BP 138/78. P 115. Patient moved to cot after she was alert and oriented. By the time paramedics arrived patient was awake and oriented. She refused transport by EMS. She left with fiancé who was driving patient.

"Staff member received 2nd dose Covid vaccine at 1355, began experiencing what she described as "similar to first dose"" (unreported) tingling in left arm approx. 10 minutes after receiving vaccine in Left arm. This progressed to tingling in her left leg/foot and 'weakened' left arm and left chest tightness 25 minutes after receiving vaccine. She reported s/s to IOH Lead at that time and monitoring began, Benadryl 25mg given P.O. BP at 1435 135/84, HR 90, Pox 100%, At 1445 Staff members reported improved s/s in arm, but right foot tingling. BP 124/79, HR 90, Pox 100%. At 1455 No s/s left arm or leg, no further chest tightness. BP 123/83, HR 95, Pox 100%. 1500 After standing for 5 minutes, BP 126/90, HR 96, Po 99%. Staff member stated she was ready to return to work. She will call fiancé to pick her up from work."

I waited my 15 minutes after getting the shot and then spent maybe another 10 finding my car and leaving the lot. I had only been driving for a few minutes, maybe less than five when I felt like my arm I got the shot in started to go numb and soon followed a feeling of lightheadness. I thought about pulling off to the side but didn't make it in time because the next thing I knew I woke up pressed against the median on the other side of the freeway I was driving on. I completely blacked out while driving. I had to call an ambulance because I was freaked out and wanted to be looked at and my car needed to be towed.

That night my fever 102 took Tylenol to bring it down, shakes, chills , nausea, muscle aches and swollen lymph nodes (right armpit).The symptoms lasted to Sunday. My estimated date of delivery was Sept.14 I miscarried at 5 wks.

tongue/face numb. Shaky/dizzy while sitting. reported arm pain. Refused ED. Rapid response evaluated. pt ambulated from cafeteria to home

830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensation internally. Medications to stop allergic reaction given by IV. Discharged home. Slight fever currently, muscle and body aches and pains. Joint pain. Headache.

Fever on 2/27 AM (99.9F after ibuprofen was taken an hour before for headache; very mild chills/nausea/hot flashes; subsided later that night), Headache 2/26 PM and 2/27. I also had a headache on the day of the first vaccine dose from Pfizer (2/4/21; EM9809 dose in AM; headache in PM).

About an hour after receiving my first dose I had a sore arm but just a normal amount for any vaccine. The next morning I woke up and felt as if I had been hit by a bus. I had an immobilizing migraine, full body aches, I could hardly eat and get out of bed, I also had a mild fever and mild cough. That only lasted about a day and a half. I didn?t find it necessary to seek medical attention and just took some ibuprofen to help ease symptoms. After both doses I noticed some light spotting the two days after. Also I did just have a baby in November but I am not breastfeeding. I work in a Pharmacy and they got me the vaccine before I returned from maternity leave.

I got the shot on February 5th, 2021. On the day of my injection, I immediately felt a stiffness in my arm within 10 minutes of receiving the shot. I didn't think too much of it because I had some stiffness in my arm with the first shot. But this Friday - March 5th will be a month and I am still having arm issues and they have gotten worse. I never had a rash or bruise on the injection site but from the injection site I have a tenderness on my arm and a constant dull and achy pain - sometimes sharp and painful - that starts at the injection site then travels down through my elbow and into my hand. My hand will get tingly and numb as well. My arm will sometimes randomly fall asleep as well. I went to the doctor but they gave me ibuprofen and that didn't do much. I am going back to the doctor soon.

It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer. Medical history was none. There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine "it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much." No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Lightheaded, feeling flushed, dizzy. Evaluated by ambulance. 3:05 pm feeling shaky. Given snack, feeling better. Discharged at 3:20 pm- symptoms resolved.

15 minutes after receipt of dose #1 patient developed blurred vision and dizziness. I arrived to the patient's side and conducting an abbreviated history as well as a neuro exam. Patient had new onset tremor in upper extremities, positive Romberg, and ataxia. HR ranged from 130-140 w/ SPO2 at 99. No signs of difficulty breathing noted. 911 was called and an ambulance was dispatched. Patient's symptoms remained unchanged upon EMS arrival and she was evacuated to a healthcare facility.

Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.

headache, body aches, injection site pain, GI upset and severe swelling of lymph nodes under my L arm (axillary region) at this time I have a golf ball sized lymph node in my L armpit that is tender to the touch

High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is still swollen. It is still hurting.; Tenderness; Feeling faint/Felt dizzy; Some trouble breathing; disoriented; Fatigue; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318), via an unspecified route of administration at left arm on 28Jan2021 at 16:55 (reported as 4:55 PM) at SINGLE DOSE for COVID-19 immunisation. It was given at a vaccination clinic. The patient had no prior vaccination within 4 weeks and had no adverse events following prior vaccinations and that was why she thought she would be fine. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included anxiety, peanut allergy, tree nut allergy, and has had anaphylactic reaction in the past. Family history included her dad has heart disease and her half sister has heart disease. There were no concomitant medications. Historical vaccine included flu vaccine on an unspecified date for immunization. The patient stated, "You kind of feel yucky after the flu vaccine, but she has never had this with a flu shot." The patient stated that she hasn't had a flu shot in years. The patient asked if arm swelling was a normal occurrence after vaccination and if side effects can last for 4 days. The patient reported that she received the first dose of the COVID vaccine on 28Jan and afterwards experienced, arm swelling, and tenderness that has last for 4 days. She also reported experiencing feeling faint, high blood pressure of 150/100 and some trouble breathing on an unspecified date and nausea. The patient further reported that she was calling because she got her first dose of Pfizer's vaccine and she was curious if this was normal and if she needs to go see her doctor and she wants to report the symptoms. After she got the injection she felt super faint and got really high blood pressure on an unspecified date. She was not sure if it was because she had anxiety, but she had trouble breathing on an unspecified date. She got nauseated afterwards. Her arm swelled up really big and the swelling has stayed there for four days. Her arm was still swollen on an unspecified date. She has allergies and has had anaphylactic reaction in the past. She was still nauseated and feels super tired. The patient asked how long do the symptoms last. The patient's weight was reported between 122 to 123 pounds. The patient clarified that the nausea started 15 minutes after she got the shot on 28Jan2021. The nausea has lasted through this. She got chills the next day (29Jan2021) after the shot. She has felt super fatigue. The swelling has gone down, but it was still swollen. It was still hurting. She has no idea if that was normal. She also felt dizzy and disoriented after getting the shot. She was not sure if it was because her blood pressure was so high. It was high for her because her blood pressure was normally low. She thinks her blood pressure 150/100 after she got the vaccine. The outcome of all the events was unknown.

I was a little tired and cold the first day but the second day i woke up with a swollen lymph node in the arm pit that i received my shot in.

Pt received first dose Pfizer vacc approx 1027. Shortly after pt stated to staff she felt, "hot" "weird" . pt appeared flush and left arm was hot to touch. Vitals taken BP 204/148, HR 149, spO2 100% RA, RR 20

The night I got my first Covid vaccine, the left side of my face started to tingle and my jaw began to hurt. I took Tylenol and Ibuprofen, but the pain didn't subside. I made a doctor's appointment on 2/25/21, which is when I was diagnosed with Bells Palsy.

hives on arms, neck on day 1. burning sensation. still hives on 3/4/21 but resolving with Benadryl, limited to arms. itchy but less severe.

Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 minutes I had hives on my chest in back. I had high blood pressure 180/120, facial puffiness and mild bottom lip swelling. I developed an onset of increased mucus in my throat causing me to clear my throat frequently. RN on site reported no throat swelling, but increased thickness due to mucus. I received a Benadryl injection on site within 30 minutes and almost immediately symptoms began to lessen. The next day I had mild bottom lip swelling, body itchiness, chest rash, headache and fatigue. Today (24 hours after vaccine) I have a headache, fatigue and body itchiness.

Headache, burning in left arm, swelling in left armpit and side along ribcage and left breast (no noticeable lumps), fatigue

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain Intermittent Chills Intermittent headache Intermittent dizziness Fatigue Soreness in arm of injection

Throat numbness, difficulty swallowing. Given Benadryl 25 mg PO. BP 136/85 (pulse 134), O2 sat 96%. F/u BP 127/92 (pulse 131), O2 sat 98%. MD rec'd ED, patient declined.

Classic symptoms of Bell's Palsy- noticed first in my eyes on 2/27 and then also in my mouth on 2/28. I was started on valtrex 500 mg TID and a steroid dose pack for 5 days. I am not in pain but full functionality of my eye and mouth have not returned yet as of 3/8/21

Day off, hives up entire arm and loss of strength in right arm. Took Benedryl to calm it. Next day, very weak and sore arm. Very little movement or strength. Third day, weak but able to slowly lift arm above head.

Patient reports back on the side of spine (right lumbar pressure). Patient reports a lot of pressure, and cannot move. Patient took Tylenol before vaccination at 10AM and was vaccinated at 11AM. Patient reports pain starting when she tried to bend down to get a dress. Then the patient experienced sharp pain thereafter where she cannot stand or move.

Systemic: Lost consciousness-Medium, Systemic: Shakiness-Mild, Additional Details: After receiving vaccine, patient lost consciousness briefly while sitting in a chair. Per a witness, the patient slowly fell onto the ground, but did not hit her head against floor or any other surfaces. She regained consciousness after a couple minutes. After resting for about half an hour, the patient was able to stand and leave the pharmacy. I escorted her to her husband's car.

At about 7:30 I started feeling extremely weak followed by coughing. Soon after my throat was tightened and it became difficult for me to breathe. My eyes have been blurry since and I?ve had a fever, cold, and my entire right side of my body hurts when I move especially from my hips down. My eyes are extremely heavy and I feel better with them being closed

Extreme arm soreness which is getting progressively worse; making it difficult to lift or move the arm entirely; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Jan2021 10:30 (at the age of 26-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. It was unknown if patient had any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included gabapentin (MANUFACTUTERE UNKNOWN), fish oil (MANUFACTUTERE UNKNOWN), ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 13:00, the patient experienced extreme arm soreness which is getting progressively worse and making it difficult to lift or move the arm entirely. Seriousness criteria was considered as non-serious. The patient did not receive any treatment for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Extreme soreness in left arm - to the point raising arm to remove clothing was difficult, migraine, sharp lower back pain, full body chills, feverish, loss of appetite, dizziness, full body fatigue.

Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had a short 'seizure-like' episode accompanied with slight shortness of breath. Pt. was also very dizzy and nauseous. Sweating came shortly after. EMS was called immediately when first symptoms began. She was responsive the entire time and reported gradually feeling better after about 5-10 minutes. EMS did a prompt check-up and revealed no unusual findings.

Very sore arm; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not available/provided to reporter at the time of report completion), via an unspecified route of administration from 22Dec2020 to 22Dec2020 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other vaccine in four weeks was unknown. Covid prior vaccination and Covid tested post vaccination was unknown. The patient experienced very sore arm (pain in extremity) (non-serious) on 23Dec2020. This report is for the first vaccination only. I will put a second report in for adverse events reported for the second vaccination as well. The outcome of event was recovered on an unspecified date. Information on the lot/batch number has been requested.

A week after my shot and I'm still having strange reactions. The day after the shot I started getting really bad cramps and other PMS symptoms like bloating and tenderness (even though I'm on a type of birth control that means I don't get a period). Then a few days later I started my period and has continued. I also have developed the kind of rash that I get when I eat wheat--all over my body and itchy and it hasn't gone done. Finally, it also caused a lot of digestive issues and bloating and gas. it makes me very nervous to get my next shot.

Patient had a minor reaction - reported feeling flush and hives. Patient developed symptoms at 30 min waiting period. She was given 50mg of diphenhydramine and observed for additional time. Patient reported feeling better after receiving diphenhydramine.

approx 2-5 min after getting vaccine, pt felt faint. pt started to lose vision (only seeing black). pt was seated and seemed to fade in and out, while staying conscious. RPH stayed with pt for following 5-10 minutes and paramedics arrived on scene. Vitals were taken, and after approx. 15 min with paramedics, they deemed her fit. Pt remained in pharmacy another approx. 30 min while she regained her faculties. She had some pain radiating in her arm and was very anxious. after a total of approx. 90 min, she was comfortable and left the pharmacy.

-fever: hot then cold frequently, night sweats and chills -muscle soreness: neck and back - lymph nodes in left armpit/chest area (I received my shot in my left arm)

Patient felt flushed and light headed/dizzy, was given water and Benadryl, recovered in 30 minutes and went home after being observed for an additional 15 minutes

Staff member called a Health Office 3-16-2021 10:40am and reported since COVID-19 vaccine #2 on 1-29-2021 IM to left deltoid, she's had constant dull, aching pain level 3/10 to her left upper arm deltoid area. States pain occasionally radiates to left axilla, but never below her elbow. Denies redness or swelling. States pain relieved with over the counter Tylenol as needed. Has appointment with her doctor 3-16-2021 for evaluation of pain.

14 hours after vaccination: Fever, full body aches, headache, full body tremors, increased thirst Next day: low grade fever, sore muscles, headache, increased thirst

Developed a sore arm around 10pm, woke up with severe 7/10 body aches that quickly worsened leading to almost fainting, and sick to stomach along with mild headache.

Upon leaving the vaccination site, I began experiencing "twitching" or mouth spasms on the left side of my face. The exact area was between the corner of the mouth and the cheek area/bone. They were persistent for the remainder of the day on 3/16/21. The twitches/spasms were similar to an eye twitch and lasted into the day on 3/17/21. The twitching subsided today, 3/18/21 but still experiencing them off and on, just not consistent or as frequent.

Patient stated that she received her vaccine in her left shoulder and then noticed a tingling of her left arm. Patient remained seated and then states that the next thing she noticed that she was being woken up by bystanders. Bystanders stated that she lost consciousness fell forward and hit her head on the floor followed by a few shaking/jerking motions and then regained consciousness after approximately 10-15 seconds. Patient denied any prodromal symptoms leading to her fall such as headaches, vision changes, lightheadedness/dizziness, nausea/vomiting, warmth, chest pain or shortness of breath. States that after waking up she noticed pain on the left side of her head where she hit her head. States that after her fall she felt fully aware denies any confused/disoriented state, tongue biting, urination or any other symptoms. Pt had a 4 x 5 cm scalp hematoma on left forehead and tachycardia. Pt was A&Ox3, was able to ambulate, and was discharged from the Emergency Department.

Patient was 18 min post vaccination when she fainted in the observation area. Nursing staff and EMS on site attended to the patient. Nurse reports "patient was sitting in observation. Patine rolled out of her chair on to her stomach on the floor. Patient was unresponsive. Time was 16:50. Patient was rolled onto her back. Patient was sternal rubbed. Patient came to 16:52. She was oriented to person, place, and time." Carotid pulse strong and palpable, spontaneous breathing. EMS vital signs; BP 100/80, HR 92, O2 sat 97%. Pt assisted to wheelchair and taken to private EMS area where she was observed, called family for a ride home. Patient refused EMS transport to hospital.

Within two hours of my shot, I had a headache/muscle aches and felt dizzy/dissociated, and left work early. I started to feel feverish in the early evening, I began experiencing nausea around 3 am that night. This became vomiting about twenty minutes later. I vomited four times over the course of the next half hour: 3:30-4:00 am. I also started experiencing diarrhea at about 4:00 am. I had five loose, near-water stools over the course of the rest of the night until around 9 am, two of which I vomited at the same time. By the time the worst of it stopped, I'd vomited 10 times from 3:30 am - 10 am. I also experienced a fever from that afternoon onward, with chills/night sweats throughout the worst of the digestive upset until the morning. I couldn't keep fluids down until midmorning 3/18 and couldn't keep solids down until that evening, around 7 pm. It's 3/19 and I've had two glasses of water and a piece of toast and still feel nauseous. A friend of mine had some Zofran, which I took one dose of around 10 am 3/18, which allowed me to keep fluids down and not have to return to the hospital.

Patient approached RN in observation complaining of dizziness. RN sat patient down, EMT put on ecg, pulse ox, and took a BP. initial vitals of 141/91, HR: 121, pulse ox: 97. Patient developed flushing in the face. IM Benadryl administered 50mg. repeat VS: 156/91, HR: 114, pulse ox: 97. Patient started to feel better, repeat vitals of 118/91, HR: 97, pulse ox: 98.

Paralysis on the right side of the face, numbness inside the mouth, swelling of face, lips, throat, and neck.

Patient complained of tingling to left arm at 10:05, no dizziness or lightheadedness, vital signs normal. Per patient, she has history of anxiety. Patient drank water and orange juice with improvement to tingling noted at 10:17. At 10:22, patient still complaining of pain/tightness/tingling in arm, so Tylenol 325 mg was given. Patient left at 10:34 stable and was advised to follow up with PCP if symptoms persist.

Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Approximately 4 minutes after receiving the vaccine, patient reported tingling of the left hand (left deltoid is the site of administration), left eye twitched once, left side of neck spasmed once and left hand tingling remained. Patient remained in the pharmacy in store clinic for 20 minutes. Patient was contacted via cell phone to follow up but no answering machine answered phone call.

For the last 7 weeks Ive had persistent tension headaches with migraines. In addition, jaw pain, ear pressure, photophobia. Have gone to the ER, urgent care, and neurology. Have tried various medication with no luck - todarol, Advil, acetominophen, methylpresidone. Notably, at the 6 week mark on 3/18/21 I received a semi quantitative antibody test specific to the spike protein which came back negative. I have previously reported to VAERS but symptoms have continued so I am filling out another form.

1/15 vaccination Early afternoon, fatigue set in. That night i spiked fever over 100 and chills fever broke 1/16 pre syncopal episodes. Did pass out while sitting down. By noon, I had fever and chills, fatigue. broke that afternoon. By 7pm I got another fever, chills, and had abdominal pain with GERD. Was not due to food as hadn't ate. Couldn't speak due to the pain. No medication taken. Husband called PCM worried about hydration. Took Tylenol and kept fluid down. Big inflammatory response. Symptoms lasted for 48 hours

She fainted, employee stated she saw her seize, EMS called and she was transfered. Intial reactiom 15:37 pm.

Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minutes after leaving 11:30 I could taste the vaccine in my mouth. I immediately felt intense sharp tingling in my lower lip, it felt hot and swollen (upper lip never had a reaction). I instantly felt a lump in my throat and had a hard time swallowing. I started with chest pain that resolved itself in a minute or two. A few minutes later a family member noticed my face was red and flushed and said I looked like I had a sun burn. Swelling in throat resolved within an hour. Lip never visually looked swollen but I could feel the tightness, burning and tingling that resolved within the hour. Redness on face resolved within a couple hours. Had tiny blisters about 3 show up above upper lip I still have them the next day with a couple more but they aren't causing problems. My airway was never blocked I never had a hard time breathing. I did have a sore throat this morning March 25 day after vaccine. All other symptoms seem normal.

As soon as the vaccine was injected my arm hurt through my neck to the back of my shoulder blade. I was immediately feeling woozy and dizzy. I sat for 20 minutes and took a Tylenol. I left the site and about 30 minutes later I was feeling extremely tired, and out of breath. Talking was difficult and taking too much energy, my shortness of breath was alarming. It went away within 4 hours. 2 days later I was feeling fine, and was sitting having a coffee. Out of nowhere I had a rapid heartbeat and started feeling woozy and light headed again. I didn't have as much shortness of breath but it felt like if I were to try and do anything it would exhaust me. I took Tylenol again and things calmed down in about 2-3 hours.

Less than 3 minutes after administration, I began having tingling in my throat. My heart began to race. I grabbed a medically professional who assessed me, she stated I was beginning to flush and then had EMS respond. Vital signs indicated a peak heart rate in the 160?s, O2 Sats were in the 80?s. I also had a metallic taste in my mouth and a tightness in my airway. Later in my hour observation I had a period of facial flushing and itching. I had ice packs placed on my skin, given a fluid bolus and monitored by an RN and EMS personal. A Doctor assessed me and contemplated transporting to the ED for management but I was slowly feeling improvement. I was monitored for an hour and felt okay when I left the clinic.

Weakness in hands, feet and legs; Facial numbness and drooping 30 mins after injection; Facial numbness and drooping 30 mins after injection; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization at age 26 years old. The patient was not pregnant at the time of vaccination. The patient had covid prior to vaccination. No known allergies. Patient was not tested post vaccination. There were no concomitant medications. No other vaccines in four weeks and no other medication in two weeks. On 12Mar2021 14:30, 30 mins after injection, the patient experienced facial numbness and drooping 30 mins after injection. On 13Mar2021 02:00, weakness in hands, feet and legs starting 12 hours after injection. Treatment was not given for events. The patient had not recovered from the events. Information about lot/batch number has been requested.

Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered. The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.

Shortness of breath; chest tightness; stated that she got the first shot in her left hip; soreness to left hip; burning at her left hip; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received BNT162B2 first dose (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 14Jan2021 at 16:20 (Batch/Lot Number: EL3249) as single dose, then via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included rotator cuff injury from 2020, unknown injury from 2018 to 2019 and repeated injuries to her shoulder (occurred before the vaccine) from an unknown date and unknown if ongoing. The concomitant medication was not reported. The reporter stated that she is a healthcare worker with repeated injuries to her shoulder that occurred before the vaccine. Stated that she had rotator cuff surgery in 2020 and the another injury 1-2 years prior to that one. Stated that the first booster that she received was three weeks ago in her hip on 14Jan2021 16:20. Stated that she went to get the second dose today in her thigh. Stated that she was told that it was being given in her thigh because it was conclusive to being effective. Stated that she was told that the first dose may not be effective. Wanted to know the current information where it should be administered. Wanted to know if she should get first dose again. Clarified that the booster is for the Pfizer Covid 19 vaccine. Stated that she got the first one on 14Jan2021. Stated that she gets repeat vaccines every year and had a declination to IM sites to the shoulder/arm area due to her injuries. No further details provided. Later clarified first booster was to her left hip. The reporter stated that with the first shot that she had soreness to left hip and burning at her left hip on 14Jan2021 16:20. Stated four days after the vaccine that she did a lot of cardio and had chest tightness and shortness of breath on 17Jan2021 16:00 within 10 minutes after that lasted for an hour. Stated burning only lasted 15 minutes. The outcome of the events the first dose may not be effective due to being given in her left hip was reported as unknown. The outcome of the events stated that she got the first shot in her left hip and burning at her left hip reported as recovered 14Jan2021. The outcome of the events soreness to left hip, Shortness of breath and chest tightness was reported as recovered 17Jan2021.

3 days after receiving the Pfizer COVID-19 vaccination, the patient reported numbness in her bilateral toes that progressed to numbness and weakness of her bilateral legs. 5 days after the onset of her initial symptoms, the patient noted bilateral numbness in her fingers and her mouth, that also progressed to weakness in her bilateral arms. A few days later, the patient noticed a right-sided facial droop that brought her to the ED. Given the patient's symptoms and elevated protein in the patient's CSF (obtained via lumbar puncture), the patient's symptoms are concerning for Guillain-Barre syndrome. The patient was started today on 5 days of immune globulin (PRIVIGEN) 10 % IV infusion 25 g.

lost consciousness; Standing and suddenly felt hot; lightheaded/dizzy; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 30Mar2021 at 07:00 as a single dose for COVID-19 vaccination. The patient's medical history included anxiety, Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient had taken other medication in two weeks are Prozac, Taytulla. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 18:00 patient experienced standing and suddenly felt hot, lightheaded, dizzy and lost consciousness. The patient did not receive any treatment for the events. The outcome of the events was recovering. Follow up information has been requested.

Employee had a seizure and LOC approx. 2 hrs post second vaccine. EMS was called and employee was transported to the hospital. Employee was hospitalized for observation. Discharged home after 2 days. Employee still reports feeling weak. Following up with primary care MD.

patient with bilateral posterior knee pain, bilateral Achilles tendon pain, and left fourth toe pain. These were severe enough to cause inability to walk

arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms; then that my vision started getting blurry; heart rate started elevating to a point where I even had to put my bf's hand on my chest to show him; lightheaded feeling; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 26-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:15 (Batch/Lot Number: EW 0150) as single dose for covid-19 immunisation . Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. The patient experienced arm was starting to go numb/get heavy on 08Apr2021 23:45 with outcome of not recovered , tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms on 08Apr2021 23:45 with outcome of not recovered , then that my vision started getting blurry on 08Apr2021 23:45 with outcome of not recovered , heart rate started elevating to a point where i even had to put my bf's hand on my chest to show him on 08Apr2021 23:45 with outcome of not recovered , lightheaded feeling on 08Apr2021 23:45 with outcome of not recovered. All the reported events were considered serious because Important Medical Events. The patient underwent lab tests and procedures which included heart rate: started elevating on 08Apr2021 , sars-cov-2 test: negative on 06Apr2021 (covid test name post vaccination: Sofia SARS Antigen FIA). The patient visited her PCP and a Bloodwork was scheduled. Follow up information has been requested.

About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; My throat was also just a little bit tight and breathing was labored/Little tightness around the throat; My throat was also just a little bit tight and breathing was labored; allergic reaction; rash all over my face; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm at the age of 26-year-old on 07Apr2021 14:40 (Lot Number: 7131121) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included lung transplant from 2016 (recipient of double lung transplant in 2016), Slight damage to the windpipe, Asthma, immunocompromised. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prednisone; metoprolol; magnesium chloride. The patient previously took cefdinir (OMNICEF) and experienced drug allergy, clarithromycin (BIAXIN) and experienced drug allergy. Patient got her shot at 2:40 pm. Seemed fine, waited at the star for 15 minutes and went on her way. About an hour after patient looked in the mirror and saw that her entire right cheeck was bright red, hot, and itchy on 07Apr2021 15:30. Her throat was also just a little bit tight and breathing was labored on 07Apr2021 15:30. Patient went to the emergency room and was given 25mg of oral Benadryl, 20mg of famotidine, and a dexamethasone shot. Patient was then observed and released once her reaction started to calm down. Consumer stated, she was calling because she had a allergic reaction to her first dose of the Pfizer Vaccine yesterday (07Apr2021). It did occur just after half an hour of the Vaccine on 07Apr2021 15:10. She broke out in a rash all over her face in Apr2021. Little tightness around the throat. Therapeutic measures were taken as a result of 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored'. Adverse events 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored' result in Emergency room/department or urgent care. The outcome of events rash all over my face and allergic reaction was unknown. The outcome of other events was recovered in Apr2021. No follow-up attempts are possible. No further information is expected.

her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; half of her face is numb; ear infection; Bell's palsy/face droopiness; Ear ache/Ear pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734 and expiration date not provided), via an unspecified route of administration, administered in Deltoid Left (reported as left shoulder) first dose on 01Apr2021 10:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication includes Multivitamin at 2 gummies once a day for immune support, bone support, and health reasons. The patient historical vaccine includes flu shot and experienced sore arm. On 03Apr2021, the patient stated that two days after the vaccine the patient experienced earache, went to the ED (emergency department) this Sunday diagnosed bell's palsy. On 11Apr2021, the patient experienced ear pain that she thought was an earache or ear infection, then she went to the ER because she woke up with half of her face numb. She says she was diagnosed with Bell's Palsy and she did some research. She says during the trials people did get Bell's palsy but they didn't know if it was connected to the vaccine. She says she is reporting it and she wants to get more information, she's due to get the second dose next Thursday. She says it was a mild case but she was concerned it will come back and come back worse. She says she has a meeting at 3 pm and it is currently 2:13 pm where she lives. The patient stated that now she was left with the face stuff, the face droopiness. The patient was still taking the Bell's Palsy medications every day, she thinks she is getting better. She says about her face being numb she woke up and felt it in her mouth, her lip, her right eye was not cooperating, there was a very noticeable difference between both of her eyes. She says she went to the ER where they did a couple of tests to see if it was a stroke or something else, they didn't do any imaging, with what they aw on her face and the way they were testing the conclusion was Bell's Palsy. She says she saw her primary care physician today because she needed to follow up and it looks like a mild case of Bell's Palsy. She says her face is getting better with medications. She says she is taking Prednisone 60 mg a day for 7 days. She is also taking Valacyclovir 1000 mg 3 times, she clarifies it says to take 1 tablet 1000 mg total 3 times a day by mouth. The events prompted the patient to Emergency room visit and physician office visit. The outcome of the event facial paralysis, hypoaesthesia was recovering. The outcome of the event ear pain was Recovered with Sequel on 11Apr2021. The outcome of the remaining events was unknown.

breakthrough seizure and frequent seizures; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 16Apr2021 13:00 (1:00PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included ongoing epilepsy and known allergies latex, bee stings from an unknown date and unknown if ongoing. No other vaccine in four weeks. The patient had no Covid prior vaccination and not Covid tested post vaccination. The patient was vaccinated at a facility. Concomitant medication included (reported as Other medications in two week): cenobamate (XCOPRI) and zonisamide (ZONISAMIDE); both taken for temporal lobe epilepsy, start and stop date were not reported. The patient previously took bnt162b2 for covid-19 immunisation first dose from 18Mar2021 at 01:00 PM in the left arm. The patient also previously took oxcarbazepine and experienced allergies (reported as Known allergies: Oxcarbazepine). It was reported that the patient has temporal lobe epilepsy well controlled on Xcopri(200mg) and zonisdamide(300mg) and experienced breakthrough seizure and frequent seizures during the last 14 hours (reported as 15Apr2021 at 08:00 PM [20:00]). Previously well controlled for the past 2-3 months, upon titration to current dose of zonisamide/xcopri. The outcome of the event was recovering. No treatment for the reported event. Information on the lot/batch number has been requested.

lost vision; migraine; unable to lift head; chest pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered at the right arm on 07Apr2021 10:45 (age at vaccination was 26 years) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lost vision on 07Apr2021 with outcome of recovered on an unspecified date, migraine on 07Apr2021 with outcome of recovered on an unspecified date, was unable to lift head on 07Apr2021 with outcome of recovered on an unspecified date, chest pain on 07Apr2021 with outcome of recovered on an unspecified date, and nausea on 07Apr2021 with outcome of recovered on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of lost vision, migraine, unable to lift head, chest pain, nausea that included migraine medication, ibuprofen, and nausea medication. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

my arm slowly became more and more sore; had a hard time sleeping; woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); stomach upset; fatigue; Little bit of chills; sluggishness; This is a spontaneous report from a contactable other hcp. A 26-years-old female patient (non pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) dose 1 via intramuscularly administered in left arm on 31Dec2020 10:00 AM and dose 2 via intramuscularly administered in left arm on 21Jan2021 12:00 PM (at 26-years-old and non pregnant at the time of vaccination )(Batch/Lot Number: EL3247) both as single dose for covid-19 immunization. Medical history included anxiety, asthma, allergies, irritable bowel syndrome from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included Sertraline HCL 100mg, Junel (birth control), Trazodone within two weeks. prior to vaccination. No other vaccine taken within four weeks prior to vaccination. Patient had no Covid prior to vaccination and not tested for Covid post vaccination. On 21Jan2021 at 05:30 PM, after second dose patient experienced sore arm slowly and became more and more. She had a hard time sleeping and woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in her entire body). Also had stomach upset and fatigue/sluggishness. Little bit of chills. All of the symptoms continued throughout the rest of the day. Therapeutic measures taken which included Tylenol at 4am, 10am, and 4pm for it. Outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.

Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for greater than 72 hours Headache for 72 hours

Started to have soreness in the left arm the day after with body aches the next day (12/30). Then developed low grade fever up to 99.9F, chills, and body aches on 1/1/21.

After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better after. About 6 days later is when I woke up with really puffy eyes. Then next day I noticed swelling on the bottom of my mouth , on both sides. Also , my whole right side of my face is swollen with a lot of pressure in it.

Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, "burning up" no fever, headache, back pain, palpitations, left axillary lymph node (peach pit size) bilateral inguinal pain next day. Symptoms improved

I received my first dose of the COVID-19 vaccine on 12/22/2020 in the left arm. Immediately at the time of the administration, I noticed numbness in my left pinky & ring finger that extended to my elbow. I figured they may have ?hit a nerve? so I called my PCP afterward. My PCP advised me to take Ibuprofen 600mg and to call the next day with any new or worsening symptoms. When I woke up the next day, I noticed numbness in both of my feet (with continued numbness in my left forearm). I had a visit with my PCP where I had a normal neurological exam except for the paresthesias. I did not sleep well the night before, so I was sent home with a medication to assist in sleeping and to observe over the holidays to see if my condition improved. Otherwise, my PCP would order more testing. Monday after the holidays (12/28/2020), my symptoms didn?t improve. I noticed that I have constant numbness in bilateral hands and feet with periodic episodes where my entire left leg and then my entire right arm had tingling/numbness/crawling sensation. I had some fasting labs done on 12/29/2020: CBC, CMP, CRP, Sed Rate, TSH, Magnesium, eGFR were all within normal limits. My B12 was slightly low at 210 (normal levels are listed as 211-911). I received a B12 injection that same day and started OTC B12 supplements. I am currently waiting on the referral to go through an EMG. Since receiving my B12 injection, I noticed a few more episodes over the New Year holiday break. From 12/31/20-01/02/21, I had this tingling/unpleasant sensation episode on my whole right side. My entire arm and leg were being affected; the episode was constant throughout most of the day with a few moments of relief with hot showers/heating blanket. No weakness noted. I currently have a message out to my PCP to update.

Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection. She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness. Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious. Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious. Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness. Patient had tachycardia and self-reported palpitations. Received IV fluids and observation on telemetry with no rhythm disturbance. Patient discharged 1428 on 12/24. On 12/29, patient returned to ED at 0326 for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation. Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619

received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00

12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Reports the rest of the day felt tachycardiac for a few hours (HR 120-140) and dizzy. Started getting muscle aches/joint aches. Denies any recent COVID exposure. Tested positive for COVID In 8/2020. Reports hips/knees are throbbing today; Heart rate WNL. /// Presenting today due to intermittent presyncope and palpitations. Also notes generalized weakness. Patient evaluate 2 L of fluid given her Mirena IUD D-dimer was sent which was negative patient with no pleuritic symptoms or dyspnea to suggest pulmonary embolism. Otherwise hemodynamically stable on exam ambulates with no difficulty no focal neurologic deficits. Patient did describe on her initial presentation that she noted some weakness of her bilateral legs. Given her possible viral reaction and description of weakness it is possible the patient is developing an early autoimmune reaction however she has no evidence of GuillainBarré or transverse myelitis on my exam. We will plan to discharge with neurology follow-up as outpatient.

I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild headache, muscle aches and felt the cold shivering feeling but had no fever.

Rapid heart rate ten minutes after administration, anxiety attack and a hot face. Lasted 25 minutes in total.

Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches

Sore arm; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration on 28Dec2020 at 08:30 AM at a single dose; and the first dose via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination, had no known allergies, and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient experienced sore arm on 28Dec2020 at 09:00. The patient received no treatment for the event. The outcome of the event was unknown.

Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.

Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 27Dec2020 at single dose shot left arm once for COVID-19 immunization in hospital. The patient's medical history and concomitant medications reported as no. Patient stated that she got her Covid vaccine on Sunday (27Dec2020) and had experienced very bad migraines on 27Dec2020, diarrhea and throwing up as well on 29Dec2020. Stated that the diarrhea was not as common as the migraines. Stated that she had not thrown up but did last night (30Dec2020) at 2 AM. Investigation Assessment reported as no. No treatment was received for the events. The outcome of event migraines was unknown, outcome of the other events was recovering.

EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include Tylenol with symptom improving.

Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted about 5 minutes but generalized weakness lasted for about an hour.

Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vaccination that has been steadily improving day by day. Have tried meclizine OTC to no effect. Vertigo is mild and not impairing. Able to keep balance fine.

Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days later I had an area of papules on my anterior thigh the size of a half dollar. The right sided back pain then began to radiate around to my hip and the rash began to be painful. My right thigh eventually began to tingle and and the pain increased in severity. On Jan 7th I presented to the acute care clinic at the Clinic and was diagnosed with shingles.

Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. About 24 hours after the 2nd dose, I noticed the area around my left collar bone was swollen . The area is painful to touch and contains a lump about the size of a dime. Pain is experienced when I attempt to cross my left arm over my body. Lump and pain still remains 51 hours after vaccination.

Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches

Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.

lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious. Information on the Lot/Batch Number has been requested.

Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle aches. 12/23-1/9 (present) 2 virtual dr visits, recommended Tylenol and rest

I woke up the morning after my shot and I had some pain around my left clavicle when putting pressure on it (turning in bed, etc. ) and I felt around and there was a small lump. Seems like a swollen lymph node. Today (2 days later), the area is more tender and a little larger upon palpation.

chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection took 650mg tylenol, able to fall asleep awoke again with sweats (did not take temperature) able to fall asleep, slept a total of 18 hours still with headache, weakness, fatigue on wakening, took 325 mg tylenol and 200 mg advil symptoms resolved approximately 25 hours after injection

14 minutes post injection, patient laid head on table and started shaking. Complained of severe headache, h ands, arms and legs numb. No resp problems. 7:50am given 12.5mg of Benadryl IM. 0800 shaking slowing down, but headache, tinglig in arms, legs still numb. 8:04another 12.5 mg of Benadryl IM given. 8:15 shaking stopped but headache continues. Legs remain "heavy" but arms normal. Patient complains of copper taste in mouth. 8:20 legs mostly back to normal. 8:30 able to walk with no symptoms at this time except for headache. Husband arrives to take patient home.

Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***

I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended up throwing up. I only got 4 hours of sleep.

Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weakness, feeling extremely hot, lip and facial numbness, tightness on throat, difficulty swallowing, shortness of breath Duration: 1 hour Frequency post vaccination: QDAY but less severe ED Visit: 12/31/2020 prescribed Zyrtec and Pepcid Symptoms still occurring going on week two post vaccination

her muscles have been spasming in her legs and arms since Saturday, she had her second COVID vaccine that day and then that night is when she started having the muscle spasms, she got the Pfizer vaccine, both doses were in the left arm, it is mostly in her legs but a little in her arms, she is not having a single spasm that lasts a long time, she describes it as a "muscle twitch" that happens once in any given location and then goes away, no muscle cramps/pain, no fever, no chills, no previous similar symptoms, she has been under more stress for the last few weeks, the only other recent change she can think of is that her OCP changed to a different generic 8 days ago

she left a message that she had a second vaccine on Jan. 7 and on 1/8 was very sick with chills, headache, shaky, and vomiting. She reports 1/9 that it is now gone (lasted about 24 hours).

At 2am that next morning January 8th (almost 12 hours post vaccine) I woke up out of my sleep delirious, light headed, heart was racing, diarrhea, and felt like I was falling in and out of almost passing out, hot flashes, couldn't think straight. It wasa very scary experience for me. This lasted about 15 or 20 minutes I'm guessing (hard to say for sure because I was too worked up to watch the clock) but I ended up making myself fall back asleep. The next day January 8th I had diarrhea multiple times in theafternoon and felt strange, somewhat lightheaded and some what felt like anxiety.

Heaviness and tingling in bilateral arms. No other symptoms. She was monitored for a total of 60 minutes. No decrease or increase in feeling. She called her mother to come and pick her up. She was escorted out of the clinic walking.

Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain like cramps and pins and needles if skin rubbed, joint pain, sharp brief headache that comes and goes in random spots of head, fatigue, malaise, mental fog

Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This is a spontaneous report from a Non-contactable Other Health Professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunization. Medical history reported as none. Known allergies: NO (Allergies to medications, food, or other products: No). The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination: No. The patient experienced Fever, body aches, joint pain, headache, diarrhea, dizzy spells, uncontrollable shakes, chills, all on 06Jan2021 21:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. No treatment received for the adverse event. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Covid test post vaccination: Nasal Swab on 07Dec2021 with result negative. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, my HR went to 180, my legs felt weak, I was having chest palpitations and chest pain. I felt really dizzy and nauseated, I felt like I could not walk. I felt like I hit by a bus. The next day I had heavy flu symptoms, high fever, continuous chest pain and high HR, at the ER they gave me a high dose of Benadryl, steroids and fluids. I took Benadryl for about 7 days and I still felt light headed palpitations and fever for almost 2 weeks. I also was tested for COVID and it was negative. I was advised to not take the second vaccine. I still have a really bad fatigue. It is the symptom that is still on and off.

Malaise, chills, flushed, temperature of 99.1 with concurrent antipyretics (acetaminophen 1000mg PO Q6H) starting approximately 20 hours post-vaccination

PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVID CLINIC WHEN HER REACTIONS STARTED. SHE APPEARED FLUSHED, AND WAS DEVELOPING A RASH ON BOTH HER ARMS, ITCHING. HER INJECTION SITE WAS RED AS WELL AS THE SURROUNDING AREA, ABOUT 1INCH IN DIAMETER. SHE REPORTS NO DIFFICULTIES BREATHING, BUT SOUNDED LIKE SHE WAS BREATHING A LITTLE ON THE HEAVIER SIDE. SHE SAID THAT IT FEELS LIKE THE LOWER HALF OF HER THROAT IS A BIT BIG AND STARTING TO SWELL. SHE WAS WALKED TO ED BY ANOTHER NURSE. ED MD FELT THE INJECTION SITE WAS INFECTED. PATIENT RECEIVED ANTIBIOTICS AND BENADRYL FOR THE ITCHING.

Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. She has been having fever, muscle aches, arm pain and chills.

Reported decreased sensitivity to touch in mouth and on face, mixing heat and cold (hot shower felt cold, cold raindrops felt scalding, trouble thermoregulating) couldn't tell where arms were, dizziness, passed out.

left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine). The patient experienced face was numb on left side since 02Jan2021. The patient also experienced pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved. The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.

Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry mouth all lasting over 36 hours.

Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (date/time of onset symptoms 1/13/2021 at 3:00PM) Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, swollen lymph nodes, and hard to swallow ( date/time of onset symptoms 1/13/2021 at 4pm and still ongoing).

I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, and vomiting that is still occurring 1/14 @ 8:10 am.

Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my neck for about an hour. As well as left sided facial pain. Worst migraine of my life. Right leg/foot spasms. Heart palpitations, difficulty catching breath, Following day-moderate neck pain, headache, and very sore left arm, nausea, left shoulder pain

The morning after getting the 2nd COVID-19 vaccination, I walked to work and started to feel more fatigued than usual within about 40 minutes after starting to walk from my apartment at 0600. I had a hard time staying awake, started to become flushed and feeling feverish at 0700 at work, and began to develop a headache and nausea around 0745. I went to sick call on my ship after realizing I couldn't power through the symptoms around 0800, and my Senior Chief mentioned earlier in the report) sent me home with motrin, tylenol, and mucinex for any congestion that may come up. Today (14JAN21) I seem to be a little more active and have an easier time staying awake, the headache and nausea have dissipated completely. However, I am still feeling more fatigued than I have been lately, and I began to feel flushed and feverish again around the same time in the morning.

felt numbness at the injection site; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; Throughout the day (Dated) it became increasingly difficult to turn my head in any direction and is very painful to move it to the left; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration from 06Jan2021 14:15 (reported as "02:15 PM") at single dose on the left arm as COVID vaccine. The COVID-19 vaccine was administered in a workplace clinic. Medical history included gastrooesophageal reflux disease (GERD), Acid Reflux Disease, Pseudo Tumor and known allergies reported as "Known allergies: Sulfate Drug, Pertussis". The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient reported that directly after the shot, she felt numbness at the injection site and stated "I realize this is normal and the shot was given properly and painlessly in the upper left arm) at approximately 2 am (12 hours after receiving the vaccine)". Patient woke up with moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line. Throughout the day on 07Jan2021, it became increasingly difficult to turn her head in any direction and was very painful to move it to the left. The events occurred on 07Jan2021 -2:00 AM. Events were assessed as non-serious. No treatment was received for the events. No Covid prior vaccination. The patient was not tested for COVID after/post vaccination. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), via intramuscular route of administration on the left arm on 18Dec2020 17:15, then the second dose via an unspecified route of administration on the left arm on 07Jan2021, both at single dose for COVID-19 immunization administered at hospital facility. Medical history included asthma, anxiety, vitamin d deficiency, eczema and rosacea, and known allergies: nickel and latex. Concomitant medications included influenza vaccine (FLU) on 11Nov2020 received within 4 weeks prior to the COVID vaccine; minocycline, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, norgestrel (CRYSELLE), colecalciferol (VITAMIN D) , calcium, and vitamin b complex received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced redness and mild swelling at injection site, sore arm on 19Dec2020. The events were reported as non-serious and no treatment was given. The patient underwent COVID test/ nasal swab: negative on 24Nov2020. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp contacted employee heatl

Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pain. Unable to life arm to dress next morning. Increasing pain, felt like a circulation problem - cold, numb, limp used ice and tylenol and aleve, day two slightly better

arm soreness (minor) day after; Headache (minor) day of; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1618; expiry date: unknown) via an unspecified route of administration (left arm), on 07Jan2021 at 12:15, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies (NKA). Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), naproxen sodium (NAPROSYN). It was unknown if the patient is pregnant at the of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 07Jan2021, at 13:00, the patient experienced headache (minor) day of. The patient experienced arm soreness (minor) day after (08Jan2021). The patient received naproxen as treatment for the events. Outcome of the events was recovered.

I had a mildly sore arm on Saturday 1/9/21. I awoke Sunday 1/10/21 and had suspected axillary lymphadenopathy on the same arm as my injection. No palpable lymph nodes on affected armpit. Mild discomfort with palpating the edema in the affected armpit. Took 600mg ibuprofen. Swelling continued into Monday 1/11/21, but had decreased in size

Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous and dizzy, sat down and became more dizzy and had loss of vision. Then laid down and a very moments later was able to sit back up. Was very sweaty and with tinnitus which lasted about 10 minutes and then Resolved itself.

Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.

Throat swelling and chest tightness three days after administration of vaccine. Symptoms were managed with over the counter antihistamines until 1/11 when the antihistamines were not working and my throat was swollen and tight, my chest was tight and my voice was horse. I got prescribed prednisone on 1/11 and have been on a long taper of that, with scheduled benadryl, pepcid and zyrtec.

When I went to get the shot, I had a firm bump with what looked like a white head on my left arm from the first shot. When she injected the 2nd dose, the bump was painful and grew twice in size on my arm and started bleeding. The technician rubbed the area for a fews minutes and the swelling went down. The bump went down, but the whole day, I felt a little sick. At around 7pm, I felt feverish, with muscle aches and chills. My skin was sensitive to touch, I felt nauseous, and I could barely walk. The bottom of my left eyelid also became a little swollen. The symptoms resolved the next morning.

Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling, constant need to clear throat, tingle/tickle in throat

Fifteen minutes following injection, the left arm broke out in hives and had numbness and tingling. Then I became dizzy and pale. I was laid down and vital signs were taken. My heart rate was in the 110s and 120s and stayed elevated for about four hours. The hives resolved and did not spread to the bilateral arm or anywhere else. The following two days I felt incredibly weak and had urinary frequency. I was told to go to the hospital by the health clinic staff but I declined.

Significant arm soreness, limited muscle rotation for 3 days. Redness around injection site and redness of bandaid mark 3 days later with multiple washes.

almost had syncopal episode from weakness; almost had syncopal episode from weakness; after my second dose, I had no until hour 12. I woke up middle of night to severe fatigue; myalgia; low grade fever; headache; swollen lymph node in L armpit; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; This is a spontaneous report from a contactable physician reporting for herself. A 27-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not reported) on 08Jan2021 14:00 via an unspecified route of administration in the left arm for COVID-19 immunization. There was no other relevant medical history. No unknown allergies. The patient previously received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not reported) on 19Dec2020 12:00 pm in the left arm for COVID-19 immunization and experienced some arm pain which lasted several hours and mild. Concomitant medication included sertraline, ascorbic acid (VIT C), ergocalciferol (VIT D), zinc, cetirizine hydrochloride (ZYRTEC). No other vaccine was received in four weeks. The patient had not had COVID prior vaccination, and COVID was not tested post vaccination. After the second dose on 08Jan2021 at 02:00 pm, the patient had no symptoms until hour 12. On 09Jan2021 at 12:00 am she woke up middle of night to severe fatigue, myalgia, low grade fever, headache, swollen lymph node in left armpit (injected left arm). On 10Jan2020, the patient was 36 hours out and she still had these symptoms but slowly improving, relieved more with ibuprofen vs paracetamol (TYLENOL). She also reported she did not receive treatment for the events. She stated that the myalgia, fatigue, headache were severe and she almost had a syncopal episode from weakness. The events were non-serious as reported. The outcome of the events was reported as not recovered.

injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.

tested positive after receiving the vaccine; tested positive after receiving the vaccine; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; This is a spontaneous report from a contactable consumer (patient herself). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. EH9899 and expiry date Mar2021), via an unspecified route of administration on 05Jan2021 on her left arm at a single dose for covid-19 immunization. Medical history included leg pain. There was no reported concomitant medications. On an unspecified date, patient received COVID vaccine. She stated that she was symptomatic during the vaccine and somewhere after confirmed that she was COVID-positive. She wanted to know if there are any health concerns with getting the vaccine while COVID positive. She added that this was her first dose. she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst but did not think that it was a symptom. She stated that she does not recall the first time ever that she had leg pain but stated that the leg pain was really bad the night before the vaccine. She added that she was isolated until 14Jan2021. Outcome of the events drug ineffective, COVID-19 virus test positive and leg pain were unknown.; Sender's Comments: Leg pain is considered intercurrent and unrelated to suspect BNT162B2.

tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report from a non-contactable other healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration (left arm) on 01Jan2021 10:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that immediately after receiving vaccine (01Jan2021), the patient felt tingle in throat, severe left arm pain, dizziness, weakness, and migraine. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible. No further information is expected.

1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning to go to a 30 min obs seat. Did not strike head, sat on buttocks and propped self with left arm; No medical Hx. BP 140/100 P 96 R 12 SpO2 100%; LOC A&O x3, did not lose consciousness; skin warm pink and sweaty; hot at back of neck; HR regular; Resps unlabored; Lungs clear; assisted to a supine on floor and legs elevated; ice pack for comfort; EMS notified 1420 BP 152/104 P 70 R 12 SpO2 99% Resps continued unlabored; EMS arrived; Handoff report given; EMS assessed; client sitting; ; client offered transport to local ED and declined 1430 Client moved back into chair; BP 136/94 P 94 R 12 SpO2 99% 1440 Client stated she was starting to feel light headed again. Moved to floor and legs elevated again. BP 140/90 P 87 R10; Resps unlabored; A&O x3; skin cool pink dry; 1445 BP 136/108 P 85 R 10 ; continues supine with legs elevated; requested that client find someone to drive her home rather than drive self; client contacting boyfriend 1450 BP 140/108 Client states she feels fine but would like to remain on the floor sitting up. 1500 Client moved to chair for further observation; VS assessment discontinued 1530 Client remains in obs and waiting for ride

Approximately 12 hours after vaccine dose: fever that lasted for 48 hours, fatigue, and extreme swelling of lymph nodes in throat, armpit, and groin. Swelling in lymph nodes of arm that received vaccine was so severe that I could not let my arm rest down by my side without throbbing pain. Pain went away after about 48-72 hours but swelling persisted for 1 week.

I started having body aches, arm soreness and a headache about 15 hours after I got my 2nd vaccine. My symptoms lasted about 12 hours and I feel completely fine now.

Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizzy. Had patient lay down, monitored VS every 10 minutes. 1750 - BP 114/70, P 85, R18, O2 100 1800 BP 127/65, P78, R16, O2 100. Drinking water. After 10 minutes heart rate felt better but c/o itching, flushed chest. Gave oral Benadryl 25mg liquid. VS 1810 BP 120/67, P 70, R 16, O2 100%. VS at 1830 BP 115/61, P70, R 15, O2100%

30 minutes after vaccine pt developed rash on arms and had tingling in right arm. No other symptoms. Gave 1 dose of 50mg benedryl and within 15 minutes the tingling had stopped and the rash went down. Monitored for 30 minutes and the pt was then released.

After having vaccine, had flu like symptoms. These worsened into dizziness, vertigo, nausea, cough, and tilgling/palpatations. Describes brain fog and disorientation/vertigo that persists until today - day of reporting.

Bottom lip swelling with right side tongue swelling and burning Lip swelling and tongue resolved by the time of awakening next morning but left slight numbness with burning at site of lip swelling as if I had novacain from dentist.

I was asymptomatic for about 6.5 hours after the vaccine was given. At about 6pm on the day I received the vaccine I noticed some injection site tenderness, minimal swelling; has been present since. Symptoms are very mild. I started having chills and hot flashes intermittently, more hot flashes than chills, have been present since 6pm yesterday. About 9pm I had a headache, muscle aches, joint pain as well. I felt feverish but temperature was 98.6F. I also noticed some axial lymph node swelling as well on the Left side where I received the vaccine. Tender to touch, not too painful though. Since received the vaccine I have had intermittent dizzy spells as well all throughout the day. I decided to go to sleep at 10:30pm and all night I tossed and turned with a headache and hot flashes. I woke up at 7:30am and was so stiff I could barely get out of bed. I called into work as I could not stand up without have dizziness. All day so far I have had dizziness upon standing, headache, myalgia, arthralgias, hot flashes/felt feverish, swollen axial lymph nodes and all I have wanted to do today is sleep. I took a nap and when I woke up I had been sleeping for 6 hours. I finally was able to get up and drink a 32ounce cup of water and take some ibuprofen. Ate some cereal. I still have a headache and dizziness upon standing that limit my ability to do normal daily functions.

Mild headache, mild dizziness, fatigue, moderate joint and muscle pain mainly in neck, shoulders, upper extremities. Currently managing with rest and did not seek medical care.

Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side face and dull tingling following three days and tinnitus bilateral worse on right ear and day four pain in both ears and TMJ and front of ear pain and sinus congestion day 6. She went to Telehealth twice personal nurse practitioner and gave Amoxil for ear pain and ENT evaluated ears,nose and throat and hearing test and covid test which exam and test normal. She stilll suffers today intermittently dull tingling right side sided of face and tinnitis both ear and headache.

Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side face and dull tingling following three days and tinnitus bilateral worse on right ear and day four pain in both ears and TMJ and front of ear pain and sinus congestion day 6. She went to Telehealth twice personal nurse practitioner and gave Amoxil for ear pain and ENT evaluated ears,nose and throat and hearing test and covid test which exam and test normal. She stilll suffers today intermittently dull tingling right side sided of face and tinnitus both ear and headache.

Sore arm right after shot and throughout the next day. Woke up in the middle of the night (around 11:45pm)with very bad chills, nausea, and headache. Temperature at the time was 99.7. Several hours later (around 3:45am) woke up again with less chills and temperature 101.6-101.8 with headache continuing. Woke up again at 5:45am with continued fever 101.7 and headache. Took ibuprofen around 6:30am and fever dissipated around 9am. Headache still continuing but not as severe.

Sore arm, left axilla pain, body aches, leg cramps, headache, fatigue, neck pain. Started 12 hours after vaccine

The night of my second covid 19 Pfizer shot, I began experiencing a strange sensation on the right side of my face near my mouth, cheek, under my eye and on my forehead. It started as a burning sensation and then turned into a dull tingling. It was consistent for 3 days and then began to become intermittent and I still have it today 1 week post vaccine. On day 4 it progressed to tinnitus right more than left ear. Day 4 evening to day 5 was all the above plus ear pain and fullness in my right ear and just pain in the left. I contacted my PCP at this point twice ( once about the initial face symptoms day 1 and to tell her about the ears day 6) and she prescribed me amoxicillin. That night I began having sinus pressure and pain, headache, and malaise. I followed up with an ENT this morning who said everything looked structurally well and could not find a reason for the tingling. She also covid tested me which was negative. Advised me to submit this form at this time due to ongoing symptoms. I will be following up with them within the next few days for further examination.

fever; pulsating migraine; joint and muscle aches and pains; joint and muscle aches and pains; dizziness; fatigue; First dose on 21Dec2020, second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular at Left arm on 06Jan2021 15:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included swine flu. Concomitant medications included buspirone, venlafaxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), ethinylestradiol, levonorgestrel (AVIANE) for birth control, plantago ovata fibre (FIBER SUPPLEMENT), probiotics and women's multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's historic vaccine included first dose of BNT162B2 (lot number: EL0140), Intramuscular at left arm on 21Dec2020 15:15 for covid-19 immunization. On 07Jan2021 11:00, the patient experienced fever, pulsating migraine, joint and muscle aches and pains, dizziness, fatigue - absolutely could not have went to work if she was scheduled that day - just moving from her left side onto her right side took immense effort and tears - haven't experienced anything like it since she had swine flu. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events fever, pulsating migraine, 'joint and muscle aches and pains', dizziness, fatigue was recovered on an unknown date in Jan2021.

flu; HR was higher than normal; fever; felt weak; dry cough; headache; muscle and joint pains; muscle and joint pains; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the second dose of bnt162b2, intramuscular in the left arm, from 12Jan2021 09:00 at SINGLE DOSE for covid-19 immunization. Patient was not pregnant at vaccination. Medical history included GERD (gastroesophageal reflux disease) and barrett's esophagus. Historical Vaccine included 1st dose of BNT162B2 on 24Dec2020 via intramuscular in the right arm for COVID-19 immunization. Concomitant medications included melatonin, pantoprazole sodium sesquihydrate (PROTONIX), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS), and algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON). On 13Jan2021 03:00, the patient felt like she had a flu; her HR was higher than normal, felt like she had a fever, felt weak, developed a dry cough, headache; and muscle and joint pains. The outcome of events was recovered. The patient did not receive any treatment for the events. Information on the lot/batch number has been requested.

left arm started tingling; roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger; heart palpitations; lower half of my face went numb; Right eye also felt weird like vibrating; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 23Dec2020 15:30 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing prior to vaccination of BNT162B2. Concomitant medication included ibuprofen (ADVIL), ibuprofen and escitalopram oxalate (LEXAPRO). The patient stated, "my left arm started tingling and it was very strong by my finger tips" on 23Dec2020 03:45 PM. The patient stated, "then the roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger. Then I got heart palpitations. The mouth tingling went away in ten minutes but then 15 minutes later the lower half of my face went numb and that lasted about 10 minutes. Right eye also felt weird like vibrating" on 23Dec2020. No treatment received for the adverse events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was recovered on unspecified date.

low grade fever of 99.4; sore joint pain on my knuckles and my wrist; felt kind of off and weak; felt kind of off and weak; Arm was a bit sore for 3 days; mild headache; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 20Dec2020 16:15 at a single dose for covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient is not pregnant. Concomitant medication included fluoxetine taken from an unspecified date for an unspecified indication. On the second day of the vaccine (21Dec2020 10:00), the patient had a low grade fever of 99.4 (no unit reported), had sore joint pain on her knuckles and her wrist, felt kind of off and weak, her arm was a bit sore for 3 days and she also had a mild headache that would come and go. No treatment was received for the reported events. The outcome of the events was recovered.

Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), muscle pain, eye pain, fatigue, fogginess

Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for Protocol C4591001 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject is in open-label phase of the study when the event occurred. A 27-year-old female with a medical history of seasonal allergies (Mar2006 and ongoing not taking any medications to treat) who received the first dose of blinded therapy (BNT162;PLACEBO) (dose 1) on 14Aug2020 at 10:34, second dose of blinded therapy (BNT162;PLACEBO) (dose 2) on 04Sep2020 at 09:27. The first dose of BNT162B2 (dose 3) on 23Dec2020 at 09:25, and the second dose of BNT162B2 (dose 4) on 11Jan2021 at 09:48. All intramuscularly in the left deltoid as a single dose for COVID-19 immunization. Concomitant medications included ethinyl-estradiol/norethisterone acetate (LOESTRIN) for birth control from May2014 and ongoing. There was no family medical history relevant to AE and no concomitant vaccine administered on the same date of investigational vaccine or other prior vaccine within four weeks. The subject experienced neuropraxia of left arm on 11Jan2021 at 09:51 considered an important medical event requiring a visit to physician office. The clinical course was the following: At 9:51, 3 minutes after receiving the second dose of BNT162B2 in left deltoid, the subject complained of left arm numbness and tingling starting at elbow and extending to fingers, weakness, and a weak grip in that hand. She also reported a decreased range of motion on the left side including her arm, shoulder joint, elbow, wrist, and metacarpophalangeal. Subject was afebrile with a normal vascular exam, no bruising, capillary refill time was less than 3 seconds. No antipyretic medication was administered. The investigator requested the subject to return to site the following day. On 12Jan2021, the investigator noted some improvement to symptoms but the subject was unable to return to work for several days after event. An appointment was scheduled with a neurologist for 13Jan2021. The action taken with BNT162B2 for the event was not applicable. The clinical outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event neuropraxia of left arm was related to the second dose of BNT162B2 (dose 4) and clinical trial procedure (vaccination administration in the left deltoid, investigator did consider the location was appropriate), but unrelated to first and second dose of blinded therapy (BNT162;PLACEBO), first dose of BNT162B2 (dose 3) or concomitant medications. Per investigator, it was not likely that the event was related to the investigational product (IP) itself, however, that could not be 100% determined until neurologist had evaluated the subject.; Sender's Comments: The event "Nerve Injury" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2). There is a reasonable possibility for the event "Nerve Injury" to be related to the procedure of vaccine (BNT162B2) administration (needle trauma) rather than to the product administered. The event would not be considered a unique response to this specific vaccine (BNT162B2). The case will be reassessed upon reception of neurological advice. Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 31-DEC-2020 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Nerve injury. Review of the database for the PT Nerve injury had the following results: 0 serious clinical trial cases and 1 non-clinical trial case. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.

Pt received dose#2 and c/o allergic reaction with faster onset. Pt reported dizziness/neck stiffness and right sided headache, nausea. States feels weak on the right side but no numbness. No slurred speech. No facial asymmetry. Pt denies any SOB/throat tightening. Dizziness less severe this time per patient. She was dizziness for 3 days with dose #1. Patient was discharged at 2112.

Had itching at site immediately rash above site developed later in the day. About 10 minutes after injection developed nausea then felt very hot became clammy and sweaty. Felt lightheaded became pale had to played down on the ground.

I received my vaccine yesterday. I waited at the location for 15 minutes with no issues. After about 20 minutes, I developed a burning sensation at the injection site. Approximately 30 minutes following the vaccine, I began experiencing an intense itching and hives of my opposite forearm. Then shortly after, my shins and front of ankles started itching. I began getting little bumps with an itch to several other areas of my body, also including redness and itchiness of one side of my face. At about 40 minutes, I also experienced a cold sensation felt at the injection site, almost like what it feels like after removing an ice cube from the skin. The itching of my skin on several areas of my body persisted for about an hour and a half. The welts and itchiness almost completely subsided at about the 2 hour mark. I did take two benedryls once I got home which was about an hour and a half after the injection. Today, the following day after injection, the bumps and itchiness are still no longer present. I have been experiencing a very sore arm at injection site and extreme exhaustion today though.

Pfizer-BioNTech COVID-19 Vaccine EUA I got the first dose on 1/20/2021, and the side effects occurred on 1/21/2021. My left arm was so painful that I couldn't raise it. I felt dizzy and got a fever in the afternoon. The temperature is around 101?. Then I took some Ibuprofen and I recovered the next day.

SEVERE shortness of breath (basically hyperventilating) for 2-3 hours, very sharp pains/heartburn in the chest when trying to take a deep breath, nausea, vomiting, diarrhea, joint pain, fatigue, chills/hot flashes, sudden uncontrollable fatigue (deep sleep for 2-3 hours after)

I developed a migraine the evening of Jan 20 and began to experience chills before bed around 8-9pm. At that time, my temperature was 99.8. I took my daily PM and migraine medication as prescribed, with no relief. Approximately 2 hours later I took the second dose of my migraine medication and rechecked my temp, it read 101.2. Around 8am Jan 21 I felt fatigued, still had a migraine, and my temp was up to 101.8. I took 2 tablets of Tylenol to reduce my fever. I did not go into work. Around 12pm my fever reached 102.1 and remained there throughout the day and I took Tylenol as described on the bottle. My migraine was greatly diminished by the evening and I did not take more migraine medication. On Jan 22 I again did not go into work. At approximately 9am my fever was at 101.2 and I called my primary care's office to seek advice about a COVID test. I did not request additional care, but the nurse recorded my symptoms and advised I was able to get tested even with the slight fever. At 2pm both fever and migraine were gone. I was tested on Jan 22 at 10am at a site, my results were negative.

Systemic: Generalized Body Aches -Mild, Systemic: Other- injection given in left arm and patient complained of muscle soreness of right thigh. Patient had also reported side effects to previous vaccines but did not note it on the consent form.

Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with symptoms occurring on and off during that period. At 1025 she felt flushed again with report of scratchy throat. No distress noted. Oxygen sats 100%. No itching or hives noted. No swelling of the face or airway but since she continued to have symptoms she was placed in wheelchair and taken to the ER.

I had sudden onset moderate left facial pain then mild weakness and numbness on the left side of my face. It?s slightly better now but has not resolved. It started about 3 hours after my vaccine. No other symptoms.

Severe L arm pain starting the day of injection. Additionally, L arm weakness. Worse pain and weakness for the first week after injection, but pain and weakness still present at the time of submission (>2 weeks from injection)

Sore arm for 3 days, chills for 7 hours, and uncontrollable lower back, hip joint, legs and neck pain/ache for 24 hours straight.

The only symptom that I noticed was a lot of pain in my joints, especially in my right hand. after three days symptom disappeared.

Feeling hot and flushed then suddenly so cold I was shaking. Massive headache, body aches, sore throat, cough, congestion, and sinus pressure.

Myalgias several hours later . Evening worsened myalgias, shivering, "burning up", no fever, headache, back pain, palpitations, left axillary lymph nodes pain, next day "peach pit size", this has improved . bilateral inguinal pain "a week for symptoms to resolve"

Staff described feeling tingles and coldness in extremities especially arms. Also became tachycardic. Emergency service called and epi-pen administered per instruction. Staff left via ambulance for evaluation. Appeared stable at time of departure.

While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling, and tingling of tongue and lips. Redness was in face, chest and right arm. Client denied difficulty breathing or throat tightness. Client reported at this time "significant hx of anaphylactic reaction." This was not noted clearly on screening form signed by client. Client given 50 mg Benadryl per standing order due to symptoms. Epinephrine was not given. 911 was called. Client vitals remained stable with slightly elevated blood pressure ate 140/102. EMS arrived before repeat vitals were taken. Lung sounds were clear and equal bilaterally. Report was given to EMS and care transferred.

Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as time passed, started hot flashes , cold flashes and shakes around 11am, right kidney (?) area on back started to hurt around 11:30am pain increasing as well. All persistent until about 5:30pm where the kidney (?) pain subdued followed by the hot and cold flashes around 7pm. Nausea and shakes passed by 1/30/21 am after I woke up. Full Left arm pain continued all day 1/30/21.

1/27 , 13 hours after vaccination (dose #2), 2:30am- strong rigors. Temp 102 1/27-1/28 SEVERE pain on the top and back of head, neck pain, and back pain. Pain untouched by consistent 1000mg tylenol and 600mg iburpofen. Also, generalized joint and muscle pain + weakness. I was unable to sit up these days. 1/27-1/29 Fevers for 3 days straight. Unable to get temperature below 99.8 even with Tylenol. Alternated 600mg Ibuprofen and 1000mg Tylenol. 1/28-1/29 Diarrhea - 5-6 bowel movements

?Pfizer-BioNTech COVID-19 Vaccine EUA? Pt had red streaking to arm near injection site approximately 10 minutes after injection, then also had chest tightness and felt like her voice had changed. Was given 50mg of benadryl by EMS with near immediate improvement of her symptoms but pt referred to ED. Pt arrived at ED and felt improved, no redness noted to site, no hives or rash noted on exam. Discharged home

Headache right after vaccine was administered. Approximately 40min after vaccine was administered I had severe dry mouth, inability to swallow, at about an hour after vaccine was administered my lips tongue and throat were swelling. Diarrhea, chills, dizziness, severe tremors.

RECEIVED 2ND DOSE OF PFIZER COVID VACCINE TODAY AT 4:15PM. APPROX 5 MINUTES LATER REPORTED NUMBNESS/TINGLING IN 2 FINGERS (PINKIE AND RING FINGERS). NO ALLERGIES, ON NO MEDICATIONS, NO REPORTED USE OF CAFFINE TODAY, NO H/O ADVERSE REACTIONS AFTER 1ST DOSE OR OTHER VACCINATIONS. 5 MIN LATER SENSATION HAD ADVANCED TO ALL 5 FINGERS. ABOUT 4:35PM HAD ADVANCED TO WRIST BUT THE NUMBING/TINGLING SENSATION WAS "MUTED" OR REDUCED. EXAMINED INJECTION SITE AND NO REDNESS. PERFECT DELTOID PLACEMENT SO NO SUSPECTED NERVE DAMAGE DUE TO INJECTION. NO H/O CIRCULATORY DISEASES OR NERVE IMPAIRMENTS. H/O 2 MIGRAINES. NO REPORTED SHORTNESS OF BREATH OF ORAL NERVE CHANGES. MIGRAINES CAN HAVE TINGLING IN HANDS AS A SYMPTOM OF "AURA". PT HAS ONLY HAD 2 MIGRAINES IN LIFE AND NO REPORTS OF PRODROMAL/AURA SYMPTOMS. REVIEWED TREATMENT IF HEADACHE ONSET TO TAKE TYLENOL AND IBUPROFEN. PT ASKED ABOUT EXCEDRIN AND WE DISCUSSED POSSIBLE WORSENING OF H/A W/ CAFFINE IF H/A IS DUE TO VASOCONSTRICTION. MONITORED PT UNTIL 4:55PM. SHE FELT COMFORTABLE LEAVING AND WOULD REPORT WORSENING TO URGENT CARE. WILL CALL AND F/U W/ PATIENT TOMORROW. REPORTS OF TINGLING PT REPORTED NO ISSUES W/ BREATHING DURING MONITORING PERIOD BUT WOULD CALL URGENT CARE IF DEVELOPED. TINGLING IN HANDS ALSO REPORTED W/ ACTUAL COVID INFECTION. PT HAS NO H/O INFECTION AND TESTS WEEKLY IN NURSING HOME. AS TINGLING IN HANDS CAN ALSO BE SIGN/SYMPTOMS OFANXIETY DISCUSSED H/O ANXIETY. SHE REPORTS ONLY MINOR ANXIETY LIKE BEFORE TESTS. NO DIAGNOSIS OF ANXIETY. SHE INQUIRED ABOUT CAMOMILE TEA AND I SAID THAT WOULD BE FINE AND WARM FLUIDS COULD DILATE AND HELP WITH BLOOD FLOW.

Skin feels like she rubbed icy hot all over her body /it feel like her face is on fire /She felt like she was running a fever but was not. She was hot and cold during the night; it burns; felt hot and cold; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 17Jan2021 at single dose at left arm for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. On 17Jan2021, the patient experienced skin feels like she rubbed icy hot all over her body, like if she scratched or touch it, it burns. There is no redness or rash. Her work just sent her home because she is required to wear an N95 mask. Her breath against the mask makes it feel like her face is on fire and she cannot wear it. She felt like she was running a fever but was not. She was hot and cold during the night, but her temperature was 98 degrees Fahrenheit. She just took Benadryl and they sent her home. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination. Information on lot/batch number has been requested.

Arm soreness, Emesis, Nausea, Urge to vomit for 24 hours, Insomnia, Lethargy, Body aches, Diarrhea

Left eye being swollen almost shut with some clear discharge; Left eye being swollen almost shut with some clear discharge; Half of the right side of her face was swelling and being numb; Half of the right side of her face was swelling and being numb; On and off chills; Sweating; Headache; Fever; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm, on 31Dec2020 at 09:30, at a single dose, for COVID-19 immunization. The patient's medical history included enlarged thyroid (normal for her), painful menstruations, allergies to cats, dogs, and dust, seasonal allergies, and birth control. The patient's concomitant medication included ethinylestradiol/ norethisterone acetate (JUNEL) as birth control. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 12Jan2021 at 06:15 AM, the patient woke up from sleep with her left eye being swollen almost shut with some clear discharge and half of the right side of her face was swelling and being numb. This persisted for about 3 days with on and off chills, sweating, headache, and a fever on 12Jan2021 (06:15). The symptoms completely dissipated on 22Jan2021. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the events. The patient got a COVID-19 test on 13Jan2021 just to be safe which came back as negative. The patient recovered from the events on 22Jan2021.

the patient felt itchy; flushed; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 10Jan2021 at single dose for COVID-19 immunization; and diphenhydramine hcl, via an unspecified route of administration from an unspecified date at unknown dose for premedication. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously had first dose of BNT162B2, lot number: EL0140, via intramuscular in left arm on 20Dec2020 at single dose for COVID-19 immunization and experienced itching. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was pre-medicated with diphenhydramine prior to the second dose of the COVID-19 vaccine. 9 minutes after the vaccination on 10Jan2021, the patient felt itchy and flushed then received oral dexamethasone as treatment for the events. The patient was sent out with oral dexamethasone home. The outcome of the events was recovering. The action taken in response to diphenhydramine hcl for the events was unknown.

Instant facial numbness on left , head rush, and chest pain. fever began 12 hours after injection coupled with body pains and general feelings of being unwell.

Patient complains of feeling hot and feverish but chilled. Pt states she has some mild tightness in her right chest and feels dizzy. She is diaphoretic. BP 136/88; HR 81; RR 15; Oxygen 100%; Temp 99.2 F

Severe headache that made face and neck and arms tingle, stiff neck, pressure in face, head, eyes, neck and arms; bodily aches; fatigue (these symptoms do happen to me occasionally due to pre-existing fibromyalgia, however after the 2nd vaccine dose these symptoms were the most intense I had ever experienced); nausea

Arm that was injected feels weaker with muscle twitching over 1 week after vaccination; Arm that was injected feels weaker with muscle twitching over 1 week after vaccination; menstrual cycle was lighter and shorter than usual; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 10Jan2021 (at the age of 27 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included GERD. The patient previously received the first dose of BNT162B2 on 20Dec2020 at 02:30 PM (at the age of 27 years old) as a single dose via intramuscular route of administration in the left arm for COVID-19 IMMUNIZATION. Concomitant medications included vitamin D3, cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), and fluticasone propionate (FLONASE). The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021, the patient experienced her arm that was injected feels weaker with muscle twitching over 1 week after vaccination and her menstrual cycle (that is usually regular each month) beginning 17Jan2021 was lighter and shorter than usual. The patient did not receive any treatment for these events. The outcome of the events arm that was injected feels weaker with muscle twitching and menstrual cycle was lighter and shorter than usual was not recovered. Since the vaccination, the patient had not been tested for COVID-19.

By 10am the day after vaccine the fever broke and I was just left with fatigue; 10 hours after vaccine I started with a fever that climbed to 103.3F overnight; This was joined by chills; This was joined by chills and body/joint discomfort as well as headache; body/joint discomfort; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number: EL8982), intramuscular at left arm on 21Jan2021, 08:15 at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, penicillins allergy and COVID-19 diagnosed on an unspecified date prior to vaccination. The patient's concomitant medications included levothyroxine, minerals nos, vitamins nos (PRENATAL VITAMIN), and riboflavin. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK9231) on 30Dec2020, 12:30 PM at left arm for COVID-19 immunization. The patient has not been tested for COVID-19 since vaccination. On 21Jan2021 18:00 (10 hours after vaccine), the patient started with a fever that climbed to 103.3F overnight. This was joined by chills and body/joint discomfort as well as headache. By 10am the day after vaccine (22Jan2021), the fever broke and she was just left with fatigue. No treatment was given for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The outcome of the events were recovering. The events were non-serious.

Intense body aches, pain from arm caused to wake from sleep, difficultly raising arm above head, strong headache that did not go away with Tylenol

The next day following the vaccine, I experienced muscle aches, headache, fatigue, febrile temp before taking antifebrile medication at 100.8 F. At the site of injection on my left arm there was a red mark and slight swelling, left arm felt weak and sore. Overall sense of unwell lasted for two days.

Client upper arms flush red and chest. Is complaining of feeling warm and headache. EMS evaluated Bp122/90, lung sounds clear. Instructed to either see PCP or go to ER. Client called Dermatologist and showed her doctor her chest in between EMS check. Derm. doctor instructed her to take benadryl Client to be driven home by family. Instructed if does not improve with benadryl to go to ER.

Patient had a hot/cold sensation. She felt both hot and cold at the same time. She had chills and felt "off." This occurred less than three minutes after receiving the Pfizer vaccine. These symptoms lasted for approximately 30 minutes. A couple of years ago she passed out after receiving the HPV vaccine.

Tingling beginning at thumb and pointer finger, progress to forearm and upper arm over 3 days. Swelling began near elbow, redness and pain followed and immobility. Visited ER on 2/3/21 and diagnosed with superficial thrombophlebitis

lower back pain, worsened to thighs, spasms developed. Unable to walk, Ketorolac injection, prednison, and flexeril. 2 days later on 12/25/2021, symptoms resolved.

first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day. was diagnosed with modified bells paulsey. with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb. FaceTime with the INT to gather this info

About forty minutes after receiving vaccine the patient noticed numbing starting in her pinky finger. The numbing radiated up her whole arm up to her jaw. This lasted about two hours and then stopped. Patient did not seek any additional treatment. No numbing has continued or started since the first incident.

Three days after both doses of the Pfizer Covid 19 vaccine, I experienced hand pain throughout the night that traveled up my forearms. On a scale from 1-10 the pain was about a 7. After the first dose, the pain went away in the morning and I was fine. On the third day after the second dose, I woke up with a rash all over my body and again had pain throughout the night only this time I woke up with swollen hands. It?s now been two weeks since my second dose and I am still experiencing hand pain, though improving. My hands feel sore and tight.

I took my second dose of the vaccine (Pfizer) on February 8, 2021. I started to get a headache later that evening and later that night I started to get chills and feel very cold with aches. I was exhausted and still had a headache as well. That morning on the 9th I had to call out, I still felt achy with a headache that lasted all day. I contacted my supervisor and also employee health. I then again had to call out on the 10th because of nausea and a headache that persisted that morning. It wasn't until later that day on the 10th that I felt better than the previous day. I also contacted my supervisor again and employee health.

12 hours after shot, woke up in the middle of the night with chills, body aches, very sore/swollen arm, headache, slight fever (100.4 degrees), fatigue. 12 hours after the symptoms first started, the headache, body aches, fever, chills ceased but intense fatigue, sore/swollen arm, and body changing from hot to cold to hot persisted. I also noticed at about 30 hours when I was showering that I had swollen lymph nodes the size of golf balls in my left armpit when I raised my arm above my head. Now, 45 hours later I feel more like myself but the sore arm and swollen lymph nodes still persist.

scratchy throat; Felt dizzy; jittery; flushed; HR elevated by NSR; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), intramuscularly at the right arm, on 25Jan2021 08:45, at single dose, for covid-19 immunization. Medical history included ongoing acne; no known allergies. Concomitant medication included a prescription medicine for acne. The vaccine was received in a workplace clinic. The patient felt dizzy, jittery, flushed and, heart rate (HR) elevated by normal sinus rhythm (NSR). All these adverse events happened on 25Jan2021 09:15. She was then monitored for greater than 1 hour with symptoms occurring on and off during that period. At 10:25 on 25Jan2021 she felt flushed again with report of scratchy throat. No distress noted; oxygen sats was 100% on 25Jan2021; no itching or hives noted; and no swelling of the face or airway. Since she continued to have symptoms, she was placed in a wheelchair and taken to the emergency room (ER). No treatment was received for these adverse events. At the time of the report, the patient recovered from the adverse events on Jan2021.

1st dose- left arm pain, especially when lifting arm, starting 6 hours later and most intense at 12 hours later, pain gone in 24 hours; 2nd dose- pain under left armpit/ lymph node, started 24 hours after 2nd dose, ongoing

Skin sensitivity that feels like a sunburn from elbow to middle of back (covering the shoulder blade on the side where the vaccine was injected). Painful sunburn sensation for the first day or two after presentation, but has lessened to more of an irritation 11 days later. Definitely still present though. No visible rash or marks.

fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.

After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left fingers within seconds. The injection site with in my left arm. Within 5 minutes, I felt some numbness in my lower lip on the right side. Within a few days, the numbness decreased along with my other, more common symptoms, such as fatigue and headache.

A few minutes post vaccination, patient complained of her ears burning, left arm was tingling. Vitals taken, MD on site assessed patient, oral Benadryl given. Patient remained in clinic for approx. 45 minutes. Symptoms improved somewhat, reassessed by MD and was discharged to home via personal vehicle with spouse.

Nausea and vomiting as well as cramping that lead to being unable to eat for a week. After a week passed, was admitted to hospital for dehydration and to make sure GI problems were nothing more serious

Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.

anaphylactic like reaction immediate flushing, redness, itching, disseminated, irregular breathing, nausea, dizziness,

Approximately 2 hours after vaccination, patient went to lunch and noted her face was numb, and could not feel when she chewed. Denies shortness of breath, chest pain, wheezing, or rash

arm soreness 3 hrs after vaccination; fatigue, chills, and frontal headache, and body aches began 6-8 hours after vaccination; sweats and fevers began 10-12 hours after vaccination and lasted 24hours after start of fevers; lightheadedness and near syncopal event 20hrs after vaccination; severe nausea around 20 hours after vaccination. Took 500mg Tylenol every few hours with very minimal relief. Fevers remained around 100-102 with medication.

Headache, Cold sweats, flushing, weakness, painful joints, extreme fatigue starting 2 hours post vaccine lasted 24 hours All symptoms have subsided except for worsening constant headache and joint pain more than 2 weeks post vaccine.

Left armpit lymph began to swell to beyond normal measures stretching my Brachial artery and plexus causing loss Of blood flow to my hand and feeling

body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on Jan2021 12:00 PM for covid-19 immunization on the left arm, also at age of 27-year-old. The most recent COVID-19 vaccine facility type was Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headache, chills, arm soreness on Feb2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

After the vaccine client started c/o seeing spots, feeling dizzy and "almost passing out". She was given water to drink, a snack and to relax. She was not given any medications. Vital signs stable. No problems since except a sore arm.

Shivers and shakes starting 9 hours after 2nd dose (Fri). Fever of 99.9 the next morning (Day 2 - Sat) with cold sweats and shakes all day. On day 3 (Sun), no fever but still extreme exhaustion and tiredness. Throwing up also started on Day 2 around 2pm and could not keep anything down. On day 4 (Mon), still extreme exhaustion that lasted until about noon. Was finally able to eat something at noon and felt back to normal by 2pm on Monday.

Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse. A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266, intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic. Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry. The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL). On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN. The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).

My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke out in hives/were itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Jan2021 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On Friday, 30Jan2021 at 11:00, the patient's face broke out in hives. They were itchy and hot, and it was sudden, over the course of 15 to 30 minutes after the itching, they appeared. The patient took cetirizine hydrochloride before bed and applied cooling balm. The hives were gone this morning. The events were considered non-serious. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.

She felt numbness in the throat, the impression was that her throat was closing up. she was also dizzy/lightheaded. her heart beat was up. she felt her heart racing as she described. Patient took self adminstered benadryl liquid, 20 minutes after the shot, 25 mg, then after 5 minutes she took another 12.5 mg. EPIPEN administered after 40 minutes of vaccine administration. 911 was called. She was shaky for 10-15 minutes after the epipen then the shakiness stopped. paramedics checked blood pressure, was normal: 120/80 as I recall. paramedica checked her oxygen saturation and it was fine. Patient didn't want to go to the hospitals , I stayed for an extra 45 minutes after using the epipen, she was normal.

Shaky, numbness in tongue, tightness in throat, tingling on tongue, evaluated by EMS-transported to nearest ER.

Shortly after receiving vaccine in left deltoid, pt complained to numbing and pain near the left shoulder. After a few minutes pt stated numbness had moved down arm and left hand was slightly darker than right hand and wrist. Pt was advised to stay in store for observation. After 20-25 minutes the pt stated that numbness has subsided and pt's left hand/wrist had returned to similar color as right hand/wrist. Pt stated that she felt much better and would leave. Pt was advised to contact pharmacy if numbness returned or if arm was tingly, or if pt had any further questions.

Exactly 14 minutes after injection, felt dizzy and nauseous. Fainted, had convulsive syncope for 1 minute, lost voluntary control of bodily function (urinated), woke up, and vomited multiple times. Vomiting lasted from 10:35am - 1:10pm. Also had diarrhea twice in between vomiting, and was shaking occasionally.

Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+ hours as well.

Client presented back at our clinic 4 hours post-vaccination. She reported that her R arm is feeling numb, similar to when an extremity 'falls asleep'. Reports tingling sensation. Reports that the feeling goes up to her head and behind her eyes. She is able to lift her arm above her head with any pain. Injection site inspected and nothing abnormal at injection site. Took patient to the EMS area at our event for further observation.

Patient feels slight tingling sensation on posterior neck, and slight tinglingsensation on L hand. Vitals: 116/69 BP 84 bpm 18 cpm 97% RA #21 pt. stable and sent home

Started as localized tingling/pins and needle sensation by injection site approximately 4 hours after initial injection.; the sensation spread to all extremities (arms, hands, legs, and feet).; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) via an unspecified route of administration on 17Jan2021 at 15:00 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not receive any concomitant medications. The patient previously received cefprozil (CEFZIL) and vancomycin from unknown dates and experienced allergy. On 17Jan2021 at 19:00, the patient experienced localized tingling/pins and needle sensation by the injection site approximately 4 hours after initial injection. Over the course of the next day the sensation spread to all extremities (arms, hands, legs, and feet). It was three weeks since first dose and sensation had lessened but still felt at times. The patient did not receive any treatment for the events. The outcome of tingling by the injection site and sensation spread to all extremities was not recovered. It was also reported the patient had not been tested for COVID-19 since the vaccine. No follow-up attempts are needed. No further information is expected.

received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and second dose on 13Jan2021; chills; fever; dizziness; headache; nausea; lack of appetite; fatigue; hot flashes; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, ), intramuscular in the Left arm on 13Jan2021 13:30 PM at single dose for covid-19 immunisation. Patient was not pregnant. Medical history was None. No known allergies. No other medical history. No other vaccine in four weeks. Other medications in two weeks included Birth control. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899, administrator route=Intramuscular, vaccine location=Left arm) on 27Dec2020 at age of 27 years old for COVID-19 immunization and nothing after the first shot. The night of the second shot (13Jan2021) patient had chills, fever, dizziness, headache, nausea, lack of appetite, fatigue, and hot flashes until the following two days (15Jan2021). Then dizziness, fatigue, nausea, lack of appetite, chills, and hot flashes for about a week (in Jan2021). No treatment for the adverse events. No covid prior vaccination. No covid tested post vaccination. The patient administered vaccine in Doctor's office/urgent care. The outcome of 'received first dose on 27dec2020 and second dose on 13jan2021' was unknown, of other events was recovered.

First, I had moderate pain in my right arm and near the injection site. After the first dose, my right arm and hand became numb with loss of feeling or touch. This lasted for most of the evening, about 12 hours after vaccination. The injection site and the muscle were in a lot of pain, which climbed up into my neck muscle. I did not have any fever or chills. For the past several days, I have become fatigued very easily. Lastly, my lower abdominal area has become sore with discomfort. I have never experienced this before, and I am not currently menstruating either. Tylenol makes it better, and resting on my back and excess movement makes it worse.

I was nauseous after the shot but it may have been hunger and nerves. I had itchy skin for a little bit on my face and arms. Then it went away. I got home around six pm. I had to go to the bathroom and first go was a mix of diarrhea and solid stools. Then as soon as I left the bathroom, I had to go back. It was fully blown diarrhea. Then I kid you not, my period came on at the same time. It is usually unpredictable but I wanted to add it just in case. And my arm became really really sore around 8pm and last night I could barely move it from the pain, or lift it. This morning it is still sore...and hurts to put pressure on .

Red eye lids, itchy, inflammation of eye lids. Soreness of arm and skin rash/slight breakout near point of injection on left arm only.

Patient discharged from vaccine event asymptomatic at 1645, returned to work, then came back to vaccine tent at 1800 stating she had a "splitting headache, was cold, clammy and nauseated." Vital signs SPO2 99% HR 72 and regular, Blood pressure 148/98, skin dry, hands cool, at this time denying nausea, still with complaints of headache. At 1830 HR 75 regular heart rate remains regular, SPOS 99%, denies any airway issues, declined water or crackers, wanted to go home.

Began feeling sick after injection. Low fever, fatigue for day of injection and day after. Day 3 felt normal, but day 4 began feeling sick again with no appetite, nausea and chills. At 5:30 I passed out and remained unconscious until my mother found me on the floor and then had a seizure lasting about 2 minutes. I was unconscious for at least 30 minutes. I have had seizures in the past, but never anything close to this.

Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EN5318) via an unspecified route of administration to left arm on 04Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient experienced with Sore Arm, Nausea, Light Headedness on 04Feb2021. Patient did not receive any treatment for events. Outcome of events was recovered on an unspecified date. No follow-up attempts are possible. No further information was provided.

Chronic hives, excessive itching, swelling of lymph nodes, skin rashes, extremely dry skin, constant muscle spasms.

Pt with hx of anaphylactic reaction to several medications. After 30 minutes, pt feels tingling and itchy skin on entire torso. No hives noted. No other symptoms. Actions Taken: Vitals taken at 1722 as follows: 135/82, HR 86, Respirations 14. O2 sats on RA 95%. No c/o shortness of breath, throat closing, itchy throat, SOB or stridor. After 15 minutes, Pt feels the same and no changes for the worse. Vitals at 1738 as follows 119/68, HR 85. O2 sat 96% on RA. Pt requests to head home and will take Benadryl upon arrival. Disposition: PT d/c to home per pt request @ 1820

About 5 minutes after vaccine, pt feels warmness in her body and sob. It resolved about a few minutes. Denies chest pain, dizziness, swelling, rash and itching.

Heart racing, dizzy upon standing, and numbness in face occured within 5 minutes of injection. Sore arm, fatigue, and feverishness set in around 5 hours after injection. Headache began about 20 hours after injection and has persisted (as of 3/18/21, 3 days after injection). Sore throat, hoarse voice, and feelings of malaise set in around 40 hours after injection.

Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.

Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, followed by cold sores

arm hurt; achy; weird lung pain; splitting headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 15Jan2021 at (at the age of 27-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified). On an unknown date after the first vaccination the patient experienced, she is achy, her arm hurts, some weird lung pain and a splitting headache. It took until the next day for her arm to hurt. The clinical outcome of the events achy, arm hurts, lung pain and headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Exhaustion Fatigue Weakness Dizziness Itchiness of injection site, face, arms Runny nose Headache

pain at injection site/ left arm; pain when raising arm; This is a spontaneous report from a contactable consumer reporting for herself. A 27-year-old non-pregnant female patient received her first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: 9266, via an unspecified route of administration, administered in left arm on 25Jan2021 at 08:45 (at the age of 27 years old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date, blood triglycerides increased from an unknown date, and drug allergy to cephalosporins from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Six hours after vaccine administration, the patient experienced pain at injection site/ left arm on 25Jan2021, and pain when raising arm on 25Jan2021. The patient did not receive treatment for the events. The outcome of the events pain at injection site/ left arm, and pain when raising arm was recovered on 26Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Pfizer-BioNTech COVID-19 Vaccine EUA Muscle cramping two weeks after shot. Felt similar to menstrual cramps, but in absence of a period (two weeks before period is due, not pregnant). Charley horse cramps. lasting muscle soreness the day after. Pain traveled around but was primarily in hip joints and pelvis.

Approx. 8 hours after the vaccine I experienced headache, diarrhea, chills and a low grade fever. Also experienced severe pain at the injection site, that worsened over the evening. All symptoms continued through the evening. Also experienced night sweats. The following morning, headache and mild chills were present, but other symptoms had abated. Had minor brain fog. Those symptoms resolved over the course of the day. All symptoms, except night sweats, have cleared up. Night sweats are ongoing.

03/23/21 -sore arm -body aches -headaches -weakness -fatigue -chills 7:00pm -102.5 fever -rash surrounding injection site -slight swollen armpit -cold sweats -headaches -body aches 03/24/21 -101 fever -body aches -chills -cold sweats

PT HAD A REACTION 10 MINUTES AFTER RECEIVING THE COVID VACCINATION. PT STARTED HAVING SEIZURE LIKE ACTIVITY THAT LAST 30 SECONDS ABOUT 10 MINUTES POST COVID SHOT; PT WAS SENT TO THE ED BY RAPID RESPONSE TEAM. PT WAS CHECKED OUT, DR THOUGHT IT TO BE A BASAVAGAL RESPONSE,BUT MONITORED HER IN THE ED. SHE WAS GIVEN NS BOLUS. AFTER MONITORING PT SHE WAS DISCHARGED.

I week after the second dose around lunch time, I started feeling numbness in my face. I went home and took my mask off and had facial drooping on my right side and the numbness on the left side. I went to the Dr. and diagnosed me with Bals Palsy and gave me prednisone, and lasted about a month.

March 14th developed numbness, tingling of tongue March 21 developed pain under L jaw, L face droop, drooling, and increased numbness of tongue no history c/w Lyme exposure, or hiv exposure

At 11:00 pm I had an extremely intense seizure that caused me to convulse on the floor while arching my back. My partner thought I was dying as it was much more intense and extreme then normal. I am still having increased seizures in both pain and severity daily. Typically my seizures last 20 minutes and are from 4-5 in discomfort in pain out of ten. Now they are around 7, even a week later. The first severe seizure was a 10 level pain and diabling. I also got severe swelling in my arm of the site, extreme pain in the my arm lasting four days, and two large cold sores. Typically my cold sores small and last for two days. Mine are still active and gave me a fat lip. I also have extreme fatigue but could be caused by the increased seizures and pain of them. I been unable to perform my normal duties and responsibilities, which my seizures typically do not interfere with.

Brought to observation area on wheel chair @ 12:07 PM, she was clammy , dizzy, pale. Layed on stretcher. @ 12:08 PM, PR 77, RR 16, BP 91/55, O2% 100, apple juice x1.@ 12:18 pm , PR 65, RR 18, BP 102/70, O2% 100. @ 12:32pm, PR 62, RR 18, BP 107/71, O2% 99 , apple juice x1. @ 12:44 PM, PR 71, RR 16, BP( Sitting) 106/70, O2% 99. Pt stated she is feeling better and she can walk out. Walked out to Exit.

27 year old female comes in 3/27/21 at 4:15pm to get Pfizer COVID vaccine. She has no family doctor. On her VAR form she states no seizure or history of seizure but does have reaction to HPV vaccine where her throat swelled up and her MD had to give her oxygen year ago. I asked about any other reactions to any other vaccinations and she said no and was willing to get this vaccine. I told her to wait 30 minutes after vaccination to make sure no reaction. At 4:25pm her sister and mom tell us that patient is feeling week and dizzy and ask for water, I go out and check and she is pale and is ready to faint. Mother asks for orange juice which she takes a sip. I ask her if she has any health conditions like diabetes, seizures and they say no, then patient has what looks like a petit mal (absence) seizure. While sitting in the chair her eyes flutter, roll back she tenses up and her body freezes for about 20-30 seconds. I tell staff to call 911 and her sister says she's having "another" seizure. We don't move her but make sure she doesn't fall, once the seizure passes we move her to the ground to lie down. She regains consciousness and is coherent but confused. I do not give EpiPen because I witnessed a seizure. The fire and ambulance arrive to assist her and then her family mentions she did have seizures years ago. After 20 minutes or around 4:50pm she feels better and does not want to go to the hospital and walks out assisted by fire/ambulance staff. The next day I call her and she says she feels better and just has a sore arm and will find new doctor check her out.

Patient reported numbness and ringing in ears after recieving vaccine. She stated she felt like she was going to pass out. Onsite HR 53 BP 116/67 Patient stated she was a runner, she recovered fully and was free to go home.

Chest pain-radiating pain on right arm; Chest pain-radiating pain on right arm Went to the emergency room-14Mar2021; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eng199 and expiration date not provided) via an unspecified route of administration, administered in left arm on 12Mar2021 10:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient is not pregnant. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced chest pain-radiating pain on right arm on 14Mar2021 19:30 and went to the emergency room. The event resulted in Emergency room/department or urgent care. The patient underwent EKG, Chest X-Ray, Blood work on an unspecified date with unknown results. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.

passed out; experienced seizure like activity; low fever; arm pain; fatigue; chills; feeling very weak and sick; feeling very weak and sick; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 11Mar2021 at 15:45 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, Ehlers-Danlos syndrome, known allergies to red food dye and sulfa; all from unspecified dates. The patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELEXA), lorazepam (ATIVAN), VITAMIN D NOS (VITAMIN D), cyanocobalamin (VITAMIN B12), curcuma longa (TURMERIC); all taken for unspecified indications, start and stop date were not reported. The patient previously took gabapentin, escitalopram (LEXAPRO), and promethazine and experienced known allergies to all drugs. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. It was unknown if the patient had Covid prior to vaccination. The patient was not Covid tested post vaccination. After receiving the first shot, the patient felt the expected side effects (low fever, arm pain, fatigue and chills) but they worsened over the next several days. After feeling very weak and sick all day, she passed out for approx 30+ minutes, she was alone but was found on the floor by her mother after she attempted to call her multiple times and she didn't respond. She experienced seizure like activity and was advised by her primary care doctor to go to the emergency room, and was seen there. Start date for the adverse events reported as 15Mar2021 at 16:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. There was no treatment received for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Cold sores lip; Swollen Left Arm; Seizures; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration administered in arm left on 19Mar2021 12:15 (Batch/Lot Number: ER2613) at age of 27 years old as single dose for covid-19 immunisation (To not die from Covid). Medical history included functional neurological disorder from Nov2019 and ongoing. There was not any history of all previous immunization with the Pfizer vaccine considered as suspect. There were no vaccines administered on same date of the Pfizer suspect. There were not any prior vaccinations within 4 weeks. There were no adverse events following prior vaccinations (she did not have any vaccines since she got the seizure disorder). The patient's concomitant medications were not reported. The vaccination was given: 12:15, kept 30 minutes because of disorder (24 hour clock). The patient experienced seizures from 19Mar2021 to 24Mar2021, swollen left arm from 20Mar2021 to 23Mar2021, Cold sores lip from 21Mar2021 and ongoing. Cold sores lip was reported as worsened. The patient stated that she had a seizure disorder and a lot of people online were saying that they had questions about seizures and the vaccine on the epilepsy site, but there wasn't much information. She had seizures for four days after her first dose. She did not have epilepsy, she had functional neurological disorder. She normally had seizures that cause her to freeze or fall or have a kick. She stated that this time though, she had the ones that most people get, falling on the floor and convulsing. She would be getting the second one but she wanted to let us know. She stated she got that Covid weight. She had seven seizures over four days. She was back to her normal with her disorder and she was not losing consciousness. She also reported a swollen left arm. She reported getting 2 cold sores. She got them when her immune system struggling. She had two on lip and that had never happened. She stated they were really inflamed and it looked like someone punched her in the lip. She usually had them for a week. She got them once a year if she was really sick, had a fever or the flu. The patient Took 2 Ativan as treatment. She stated that it kind of helped but not really. She took it on 20Mar2021. She also took alcohol because it usually lowered the seizure threshold and she won't get any but it wasn't helping. The patient was having an increase and change in type of seizures after receiving the first Covid vaccine. She had an increase in her normal seizures. They were normally 3-4 minutes and she medicates them away. Those started around 16:00. She stated they then got too powerful and too many for too long around 18:00. At 20:00 she had seizures where she would lose consciousness and fall to the ground. She had 6-7 of those. She stated that each day they were getting weaker and weaker. She stated the one at 20:00 was 10/10 painful and scary and people thought she was dying but she was not. The events did not require a visit to emergency room or physician office. She stateds that they were in a different state, they went to an island and decided if she had second one that night then would go but she didn't. She stated that she was not supposed to go [to the emergency room] unless they last 5 minutes or longer and hers lasted 3 minutes. The outcome of event seizures was recovered on 24Mar2021. The outcome of event swollen left arm was recovered on 23Mar2021. The outcome of event Cold sores lip was not recovered. Follow up attempts are needed. Further information has been requested.

Arm pain for 12 hours, fever for 4+ days, aches and chills for 4+ days, sore throat for 4+ days, fatigue for 4+ days

About 15 minutes after injection patient reporting shortness of breath , difficulty swallowing. throat felt swollen and tingly sensations. On assessment patient clear but diminished breath sounds, thready/weak pulse, swollen lips , BP 130/80. At 1359 pharmacy gave first dose of Epi in left leg, pt symptoms only mildly improved, then second dose of epi given at 1406. ER rapid response on site to take patient to ER and assume care.

Woke with up chest, arm and jaw pain on 03/21/2021. Presented to the ED. Her initial EKG was negative for any acute changes but her troponin was elevated. Cardiology was consulted. Her echo was negative for cardiomyopathy or hypertrophy. But after her troponin continued to rise she was taken to the cath lab to look for ischemia. Her cardiac angiography was negative for obstructive disease, and coronary arteries were completely normal. Had low magnesium and potassium- so started on oral supplementation. Discharged on 03/22/2021 with nitroglycerin (which was not helpful and made her feel worse/nauseated) and to follow up with outpatient cardiac MRI and cardiology. This imaging revealed significant myocardial edema consistent with myocarditis. 04/01/2021 Per Cardiology: -Given that the patient had covid 19 back in November 2019 I believe she may have had a low yield subacute myocardial infection at that time that was somehow exacerbated by her 1st covid vaccine. Therefore, after some consideration and careful discussion I am advising against the 2nd vaccine at this time. -No physical exercise for 6 months given her current myocarditis and family hx of sudden cardiac death -May trial PRN NSAIDS for pain relief -Recommend birth control and no pregnancy until at least after her follow up cMRI -Follow up in 6 months with cMRI prior

AFTER 5 MINUTES OF RECEIVING 2ND DOSE OF PFIZER COVID 19 VACCINE. THE PATIENT COMPLAINED OF PALPITATIONS AND WAS JITTERY. SHE DEVELOPED RASH ON CHEST. 911 WAS CALLED AND EMS CAME AND TOOK PATIENT AWAY FOR OBSERVATION

I received the first dose of the Pfizer/BioNTech vaccine on April 15, 2021 at 3:00PM. On April 17, 2021, I began experiencing involuntary body jerks. They initially felt like hypnogogic jerks, but I was fully awake. The body jerks primarily occur in my trunk (seldomly in my lower extremities) and are visibly noticeable. These myoclonic jerks increased in frequency over the course of a few days since they first began on April 17th (up to 7-10 times within a 15 minute span). It has been 3 weeks since my first Pfizer vaccine dose. I have not received a second Pfizer vaccine dose. The jerks are persistent; they have not decreased in frequency or intensity. As an aside, I am concerned about these body jerks because I am a medical student who plans on going into a surgical specialty and this will severely disrupt my career. I received one dose of the Janssen Covid-19 vaccine at 6:45 PM on May 5, 2021.

Severe arm pain. Throbbing. Muscle spasms at injection site. Numbness and tingling in fingers on affected side. No treatment appears to improve conditions.

Fever; Chills; Body aches; Migraine; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9269) at 13:15 at single dose for COVID-19 immunisation. The relevant medical history included fibromyalgia. Concomitant medications included spironolactone. The patient previously received the first dose of BNT162B2 on 13Jan2021 (lot number: EL3249, administration time: 12:45PM, vaccine location: Left arm) at the age of 27 years old for COVID-19 immunisation. The patient experienced fever, chills, body aches, migraine, nausea, dizziness on 04Feb2021 at 09:00 AM. No treatment received for the events. The outcome of the events was recovered on an unspecified date in Feb2021.

tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.

AT 10:38, patient reports feeling anxious and tingling sensation at the occipital area / behind her ears. She denied any flushing, dizziness, headaches, cough, sob, numbness sensation around her mouth, chest discomfort

Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated feet. Went to ED, per patient did not receive any medications, just had an EKG.

Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced left sides shock like pains in head, lasted 3-5 seconds and went away. It's a stabbing shock like pain. The events started on Thursday 17Dec2020 at 19:45. It was unknown whether treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the event left sides shock like pains in head is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.

within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushed feeling. Rapid response called observed, provided water and ice. Felt dizzy when tried to walk. Observed for 45-60 mins.

Day of administration around 2100 I started feeling a little off, got a little bit of a headache and felt warm. While sleeping I could feel that I had chills and felt very warm. Woke up at about 0200 to take my temperature. Felt dizzy when I got up, still had a headache and a fever of 101.0 (taken orally). Contacted a nurse triage line to ensure I can take t=Tylenol to bring the fever down and get rid of the headache. She said yes, which is when I took 500mg Extra Strength Tylenol rapid release. Continued to feel not so well, and broke my fever around 0630 timeframe. Once I woke up around 0900 (day after administration) still felt a little warm (99.5) and a mild headache. Will keep an eye on any other adverse reactions.

Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscularly in the left arm, on 21Dec2020 at 07:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. Medical history included migraines and allergies to mango. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included magnesium (MANUFACTURER UNKNOWN) taken as supplement. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (99.6), arm soreness, headache, and fatigue on 21Dec2020 at 20:00. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: 99.6 on 21Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of fever (99.6), arm soreness, headache, and fatigue was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous report from a contactable consumer reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2 ; Lot # EK9231) vaccine , via an unspecified route of administration on 27Dec2020 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to amoxicillin sodium on an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced about one minute and a half after receiving the vaccine racing heart rate on 27Dec2020 with outcome of recovered , restlessness on 27Dec2020 with outcome of recovered , dizziness on 27Dec2020 with outcome of recovered , shaking on 27Dec2020 with outcome of recovered , breathlessness on 27Dec2020 with outcome of recovering , nausea on 28Dec2020 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: racing on 27Dec2020. The patient received diphenhydramine (BENADRYL) to treat dyspnea.

Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minutes, her symptoms returned and another Epinephrine given IM

Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, via an unspecified route of administration in the right arm on 30Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included an allergy to tegaderm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen, zinc, methocarbamol (ROBAXIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took chlorhexidine and experience allergies. On 30Dec2020 at 21:30, the patient experienced arm sore/upper arm sore, itching surrounding vaccine site. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the arm sore/upper arm sore, itching surrounding vaccine site was unknown.

I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230. At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.

After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, syncope, difficulty breathing, numbness & tingling in hands and feet. Measured temperature of 102 F. Slept most of the next day and missed work x 1 day. The following day was improved but still with moderate fatigue and nausea. Took ibuprofen with some improvement.

Arm soreness, fever (101.5F), chills, rigors, headache, and body aches. The fever and chills were refractory to ibuprofen and required both ibuprofen and Tylenol to break. The fever and chills continued for 24 hours and the headache/body aches continued for 36 hours, the arm soreness has improved but is ongoing.

Significant arm soreness and generalized body aches about 9-10 hours after the vaccine. Lasted about 24 hours and prevented me from performing daily activities or working.

had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.

15 minutes post injection had numbness and tingling in left arm, complained of feeling cold, tingling started in her back too. Called for rapid response and patient was transported to ED>

Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.

Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling crummy" - fatigue and "really bad" headache. She went home after work and went to sleep. 12/29 onset of feeling "hot" but her temperature is normal. Body aches, slight headache, and feeling "clammy". She took ibuprofen on 12/29 and is currently at work. Employee reports she usually feels mildly ill the day after a flu vaccine but this adverse reaction is much worse than that. 12/30 - employee reports she developed diarrhea and a temp to 99. Continues to have body aches and mild headache. 12/31 all symptoms resolved.

I have like tingling and it is not really numbness but feels like my hands are asleep; I have like tingling and it is not really numbness but feels like my hands are asleep; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on at single dose for preventive measure for Covid. Medical history included postural orthostatic tachycardia syndrome, migraine, cardiac disorder and ventricular tachycardia. Concomitant medication included sertraline hydrochloride (ZOLOFT), topiramate (TROKENDI XR) and nadolol. The patient stated that on 31Dec2020, "I have like tingling and it is not really numbness but feels like my hands are asleep". The patient underwent lab tests and procedures which included weight: 130 lbs on an unspecified date. The outcome of the events was unknown.

Patient began experiencing itching at the injection site and then all over her body. She started feeling very warm and developing hives. She was given diphenhydramine 25mg by mouth. 911 was called and she was taken to the ER. The ambulance arrived about 5 minutes after 911 was called.

Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling in my cheeks.; My left arm also was extremely hard, sore, and tender/swollen.; My left arm also was extremely hard, sore, and tender/swollen.; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on 22Dec2020 16:00 at single dose at arm (for confirmation) for COVID-19 immunization. Medical history included anxiety. The patient's concomitant medications were not reported. On 22Dec2020 17:00, Shortly after receiving the vaccine the patient felt a flushed feeling in her cheeks. The patient's left arm also was extremely hard, sore, and tender/swollen. About an hour afterwards, 18:00 I got a pulsating headache that lasted for 3 days. It was only mildly relieved with Tylenol and ibuprofen. It felt similar to a migraine and accompanied with some nausea on 23Dec2020 day 2. The patient received treatment for the events. The outcome of the events was recovered on an unspecified date in Dec2020.

Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.

Sxs started 2 hours post vax with flushing, palpitations, chest pressure. Presented to ED. Sxs resolved after 2 hours of observation.

Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tongue and inside of the mouth was itchy, rash on upper body and swollen inflamed painful lips.

The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I went to bed. The day after my second vaccine, the entire day I felt extreme arm pain, full body aches, chills and had a fever. It was hot in my room and I was wearing multiple layers of clothing and laying under my blankets, shivering. It was very uncomfortable and lasted much longer but I had heard the second vaccine was a bit more intense so I figured this was to be expected. The following morning I woke up feeling like brand new.

Arm soreness starting the next day after injection and lasting for 4 days Fatigue starting about 6 hours after injection and lasting for 2 days Brain fog starting about 6 hours after injection and lasting for 2 days Mild headache starting about 6 hours after injection and lasting for about 4 days

- Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myalgias and arthralgias, fatigue - 24 hours max temp 99.9, chills, sweats - Symptoms all resolved by 36 hours after vaccine

1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Fever resolved. Fatigue and muscle aches still noted

Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours after shot

About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grade fever of 99.9, chills, headache, nausea and fatigue that persisted until Friday evening. Saturday I experienced a headache and nausea, loss of appetite and whole body fatigue and soreness in back, neck and arm. Headache, fatigue, loss of appetite and nausea persists till now (Monday/Day 4)

Approximately 10 minutes after receiving the vaccine she started experiencing numbness and inability to move all 4 extremities. No difficulty breathing or swallowing. Benedryl 25 mg was administered with no relief. EMS was called, she was transported to the ED and admitted to the hospital for evaluation. She was given Ativan 0.5 mg IV with some mild improvement in symptoms. She has had gradual improvement in her symptoms, now able to move her arms normally. She has persistent weakness and discomfort in both lower extremities and is unable to ambulate without assistance.

Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30 minute period onset of fever, myalgias, chills, and nausea. Called off work from my job as a flight nurse at midnight. Tried to sleep it off until about 0430 when the body aches became unbearable. Ate a few bites of yogurt and took 400mg of ibuprofen. No change in symptoms until 0530 when I took a hot shower which helped relieve some muscle pain. Took 400mg ibuprofen again at 1030 with a small snack with no change in pain or fevers. Took hot shower again which helped briefly. Nausea subsided around 1630, enough that I had a small meal of bland food and another 400mg of ibuprofen. By 1700 more tolerable myalgias and fever came down some. 2230 another 400mg dose of ibuprofen, fitful night of sleep waking again at 4am with shooting lower back pain and fever. Took another dose of 400mg ibuprofen and a hot shower. Woke up at 1000am sweaty with mild myalgias and low grade fever. Took another dose of ibuprofen 400mg, 30 minutes later profusely sweaty but afebrile. Fatigued all day and poor appetite until late evening. Woke up next day after better night of sleep at 0730. Mild fatigue and bad heartburn all day and night. Left arm still sore to touch. This morning (1/11) feeling mild heartburn but better.

On 01/05/21 at 6:30 A.M. the patient woke up and noticed facial right side quivering. On 01/08/21 the patient noticed right side of mouth raised on Sat. 01/09/21 the patient noticed at 4:30 P.M. right side drooping of right mouth corner. The patient went to to the emergency room at Medical Center at 2:30 P.M. The patient was treated with prednisone 20 mg 3 times a day for 5 days.

Patient reported a tender lump on the left side of neck that was tender to the touch. The lump presented exactly 1 week after the 1st vaccine dose, and it was noticeably swollen. At the time of 2nd dose, the lump was no longer visually noticeable, but could still be felt to the touch. The residual lump is no longer tender to the touch.

My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles were achy, felt weak, my neck was sore and I had a knot at the injection site. I took 400 mg of ibuprofen around 7am on 1/12 and my symptoms subsided until around 3pm and started getting chills and leg aches. My arm developed redness right where the knot is on my arm and I still have the knot today (1/13). I have had no other symptoms since 3pm 1/12.

dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and broke out in rash around injection site; pain and stinging on injection site location; heat and redness as well as a raised rash; heat and redness as well as a raised rash; Both ears got, rot and itchy, stomach itchy; Both ears got, rot and itchy, stomach itchy; fever of 100.7; sever heart burn; severe body aches; head ache; raised rash; This is a spontaneous report from a contactable other Health Care Professional (HCP) who is the patient. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown, expiration date unknown) via an unspecified route of administration on 04Jan2021 at 10:00 AM (at the age of 28-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included removal of a metastatic carcinoid tumor from an unknown date and unknown if ongoing. The patient's allergies include minor hive breakouts from "several things." The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 17-DEC-2020 at 14:00 (at the age of 27-years-old) at an unspecified dose in the right arm. The patient was not pregnant at the time of this vaccination. The patient was administered the vaccine in the hospital. Prior to this vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included drospirenone;ethinylestradiol;levomefolic acid (reported as "generic form of Beyaz") and acetaminophen.The patient did not receive any other vaccines within four weeks prior to the first vaccination. On 04Jan2021 at 10:00 PM the patient experienced severe body aches and head ache, through out that night. She had dizziness and nausea with increased joint pain and body aches with the head ache increasing as well. On the morning of 05Jan2021 she experienced a fever of 100.7 and body aches. On that same day in the afternoon these symptoms subsided. She also experienced severe heart burn on 05Jan2021 that did not subside with Tums. On Wednesday 06Jan2021 she was feeling much better, and she had a "normal day." At 12:00 AM on 07Jan2021 the patient started itching and broke out in a rash around the vaccination site, and pain and stinging at injection site. She also had heat and redness as well as a raised rash. Both ears got, hot and itchy, her stomach was itchy but not red or swollen, same for the right leg and foot. She took one allergy pill, and twenty minutes later was still having a bad reaction so she took another allergy pill. She stayed awake to fill out this form, and she was hoping the reaction would stop spreading. Treatment was reported as having taken Tums for the severe heart burn and the patient also took an unspecified "allergy pill" for the itching, vaccination site rash, pain and stinging, the heat, redness and raised rash, the red, hot itchy ears, and the itchy stomach. The clinical outcome of the events severe body aches and fever was reported as recovered on 05Jan2020. The clinical outcome of headache, dizziness, nausea, joint pain, heartburn, vaccination site rash, vaccination site pruritus, vaccination site pain, feeling hot, redness, itchy, ear disorder and raised rash was reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly burning sharp pain, but some restricting tight pain as well, radiating to my back mostly. It would be relieved for maybe 10 minutes at a time but then flare back up for about 5 hours. I went to the emergency room, where they did a cardiac work up including blood work and EKG, vitals and a chest X-ray, all which were unremarkable. At about 0200 am on 01/13, the pain subsided. Previous to the chest pain, during the morning and afternoon of 01/12, I had a low grade fever (99.9 F), an intense headache, and fatigue. 01/14/21 sore swollen lymph node under L arm.

Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Benadryl 50mg before bedtime. 2 days after vaccine: woke up with voice changes, coughing/choking with speaking. Used epipen once, felt full relief for about 1-2 hours. Trouble speaking again. Then went to ER, had epipen again twice, over two hours, Benadryl 50IV and Pepcid and steroids. Sitting in the ER now debating admission. Likely being admitted., home epipen are too expensive to treat q2h by myself.

Fatigue on the same day of the vaccine and the next day. Left arm soreness for about 2-3 days after the vaccine.

Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.

I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violent and coarse rigors, severe enough to contract the spine into hyperextension if I kept my body in a neutral position. I could still activate each muscle group to keep in a fetal prostration pose. I was knowledgeable of the event, did not loose any bowel, bladder, or smooth muscle function, and the intensity of the rigors was focused on the most developed skeletal muscles (thighs, calves, upper arms, forearms, paraspinal muscles, hands, respectively). Jaw and muscles of the head/face seemed unaffected. Fingers and toes not distinctly affected. I was not sweating at this time and there were NO other symptoms to report; I remained lucid and able to self-reflect the entire time. Home temperature is kept to consistent 66F, no malfunctions to thermostat. No recent changes to bedding (sheet and quit on top of mattress); it is even optimized for me as I tend to overheat as I sleep. At 50 minutes, I felt "less frozen" and confident enough to stand/ambulate for 220mg naproxen + 500mg APAP , cautiously and successfully swallowed. Robe was donned over existing pajamas and thick comforter was pulled from hallway closet. Rigors continued, but it appeared that intentional activation of the muscle groups could still overpower the rigors for safe (but shaky) ambulation. Greatest risk was coarsely shaking hands a bringing cup to mouth to swallow pills. Above activity was completed in 5 minutes. I then sat upright in bed under layers above. I could feel the muscles calm and relax, with episode completely ending in 5 minutes. Total time of event: 60 minutes. Post-event details: There was a mild sensation of muscle tension in the posterior cervical spine akin to whiplash, but no residual symptoms. I debriefed with my husband shortly thereafter (he has been in another room the whole time) and fell asleep by 23:30. Awoke to alarm at 05:00 and able to stretch, accomplish 30 min run, vacuum/mop the floors, and present to work by 08:00am without deficit. Time of documentation: 11:22 am 1/15/2021

Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin tingling, joint pains, muscle aches

The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen lymph nodes in the pectoral area (as all other testing at the ER was normal). Also sharp pain when breathing in deeply.

Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and sweaty with a headache and body aches

headache; arm pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included Postural orthostatic tachycardia syndrome. Concomitant medication included spironolactone and metoprolol. The patient experienced headache and arm pain on an unspecified date after first dose (reported as "First dose: headache, arm pain"). No treatment received for adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/ batch number has been requested.

Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, fever, headache, nausea and 1 episode vomiting, myalgia throughout body, dizzy/lightheaded ness and extreme fatigue. The next day Jan 16 had diarrhea all morning

2 hours after the administration of the vaccine, the left side of my face briefly started to tingle. I slept for 6 hours, and when I woke up, the left side of my face was noticeably having pins and needles. I took 25 mg of oral Benadryl and slept for another 7 hours, and when I woke up, my left arm and leg were experiencing pins and needles. The left side of my face was completely numb, and I felt like that side was being pulled down toward the floor. The left, posterior side of my head felt very tingly, and I had a pounding headache behind the left eye that worsened with light. My boyfriend noticed my smile being different, and after looking in the mirror, I decided to go to ED. They were concerned about Bell's Palsy, but with the extremity involvement, they changed my plan of care to a migraine response from the vaccine. I received an MRI, IV Compazine and IV Toradol. My headache went from a 6/10 to a 2/10 after that treatment, but it came back soon after my discharge.

After 1st dose, feeling of fatigue and extreme heat, soreness in left arm and headache After 2nd dose, headache, soreness of left arm, and night fever 24 hours later

After almost 15 minutes of receiving vaccine, my mouth, inside and outside, tongue and face wer very tingly and cold. It came from no where. I could even feel it on the top of my mouth. I did not have any trouble breathing or swallowing, it felts like everything fell asleep and that I chugged ice cold water. It lasted for about 40 minutes.

I received the dose at 12:00pm Saturday and by midnight I was awoken with severe 9/10 pain to my left arm radiating up my left side of my kneck to my ear and down to the middle of my back. This follows Sunday morning with muscle aches, joint pain, headache and nausea. Continuous nausea occurs until vomiting starts sunday mid afternoon. This all continues until Tuesday morning when a Phenergan shot IM is able to be administered at urgent care where I return home and sleep for 24 hours. Tiredness and weakness continue until the morning of Saturday 16th where I wake up feeling "normal" in a sense.

Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calming down after 10 minutes and drinking water. Her face did appear flushed but she also said it was flushed before she got the injection. No difficulty breathing, no obvious urticaria. She was emotional about losing her mom to anaphylaxis at age 10, stated that her sister also has similar allergy profile. She questioned if she should et the second vaccine dose.

Starting 6 hours post vaccine - arm started to feel sore, unable to lift straight up without soreness 8-10 hours after - headache began, treatable with tylenol -- Tylenol dose lapsed Overnight arm increased in soreness, could not sleep because if arm moved it woke me up First thing the next morning - could not lift arm past shoulder, body felt stiff/sore/ very fatigued, headache -- tylenol helped get through the work day -- Extreme fatigue - took a 2 hour nap after work and still had to go to bed by 9p The following day (48 hrs after): dull headache + sore arm but significant improvement - took tylenol to help Arm stopped feeling sore after 72 hrs and no longer had headache.

difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

1/14/21 severe chills , fever of 101.9, treated with ibuprofen throughout entire day, sweats, headache, fatigue, body aches, nausea, soreness at injection site 1/15/21 headache, fatigue, body aches, nausea, dizziness, soreness at injection site, numbness and soreness of right 5th metacarpal; took ibuprofen for headache 1/16/21 headache, dizziness, fatigue, nausea, body aches, numbness and soreness of right 5th metacarpal 1/17/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal; took Tylenol for headache 1/18/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal 1/19/21 tiredness, nausea, numbness of right 5th metacarpal

Got the second dose vaccine around 1:45 and was feeling completely fine. I was about to leave at 2:00pm when my heart rate started to increase. I took some deep breathes and started to feel better. Then as I walked out to my car and on my drive home, my whole face felt like some type of electricity was racing through it. I would touch my face and wherever I touched, the skin would feel tight and tingling. This lasted for 30-40 minutes and never came back.

Pt. described feeling as if her cheeks and front of tongue were slightly swollen. She also noted tingling of lower legs. She denied any throat tightening, no trouble swallowing or difficulty breathing, no chest tightness as she has experienced in exercise induced asthma. (Note: forgot to add under chronic conditions with only rare use of rescue inhaler).

Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection site)

Alternating sweating and cold; Alternating sweating and cold; stomachache; Nausea; Fatigue; Headache; This is a spontaneous report from a non-contactable healthcare professional (reporting for herself). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 10:45 in right arm at single dose for COVID-19 immunization. Medical history included hypothyroidism and major depression from an unknown date and unknown if ongoing. The patient had no allergies to medication, food, or other products. The patient had first dose of BNT162B2 on 18Dec2020 15:00 via intramuscular in left arm at single dose for COVID-19 immunization. Concomitant medications included levothyroxine, bupropion hydrochloride (WELLBUTRIN), "birth control" (not further specified, and escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, the patient experienced alternating sweating and cold, stomachache, nausea, fatigue, and headache at 1:00 AM. She was not hospitalized, and the events were reported as non-serious. Therapeutic measures taken as a result of the headache and included acetaminophen. The outcome of the events was resolving. The patient underwent lab tests and procedures which included nasal swab: negative in Nov2020. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Since the vaccination, the patient has not been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are needed, information about lot/batch number cannot be obtained. Follow-up (14Jan2021): This is a follow-up report combining information from duplicate reports 2021013335 and 2021015838. The current and all subsequent information will be reported under manufacturer report number 2021015838. Additional information included: reaction data (alternating sweating and cold, stomachache, nausea, fatigue, and headache). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Arm pain which lasted 3 to four days - I Got a headache a week after the vaccine. I saw my neurologist and she prescribed a prednisone 50 mg for seven days. It resolved it for that week.

Fevers, uncontrollable shaking, chills, sweats, muscle aches, chest tightness, painful enlarged left axillary lymph node, left arm pain, fatigue, weakness, and nausea. Adverse effects started approximately 12 hours after vaccination and lasted up to 48-72 hours.

Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM. After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo; additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.

12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOSE (AFTERNOON/EVENING): WORDS/CHALLENGES COMMUNICATING FOR 24 HRS

At approximately 9pm the night of the vaccine 2nd dose, I developed a fever. As the night progressed, I also developed severe R arm pain, joint pain, muscle aches in my back, chills, a headache, and fatigue. The fever was as high as 103.1 and improved with tylenol, but lasted for 2 days. Since onset of the back pain, it has persisted and gradually worsened over the past 2 weeks since the injection. I contact my physician, received a prescription for a muscle relaxant, and a referral for physical therapy.

I just wanted to report an incident that occurred after receieving the first dose of the covid vaccine. It was not one of the possible reaction from covid vaccine but rather administrator error in injecting the vaccine. The symptoms appeared about 3 hours after receiving the vaccine, now have numbness, tingling, pain and burning sensation on my left pam in the arm of given vaccine. Obviously, the person giving the vaccine, hit the nerve.

One hour after vaccination patient experienced Left facial and tongue numbness that impacted her ability to speak clearly (similar to experience with numbing for a dental procedure). She was given 25mg diphenhydramine orally and taken to the ER. Dexamethasone 10mg given intramuscularly in ER.

Patient experienced left facial and tongue numbness which impacted her ability to speak clearly (similar to numbness experienced with numbing prior to a dental procedure). She was given 25mg diphenhydramine orally and taken to the ER. She was given 10mg dexamethasone intramuscularly in the ER.

Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after vaccine given. Patient also noticed stiffness in neck, feeling of pins and needles and some skin burning. Additionally endorses feeling a dry mouth sensation.

Bells Palsy diagnosed after 8 days from start of symptoms. Initially, I went to ED for left sided facial numbness and weakness, along with left sided headache and upper/lower parasthesias. They half treated me with 1L Sodium Chloride bolus, Compazine IV and IV Toradol for a migraine. This took 4 hours. It was my PCP who I saw 8 days later that started me on Imitrex for the migraine and a 13 day treatment of tapered Prednisone, along with 10 days of 5x a day acyclovir. I am currently on day 4 of this treatment.

13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135/80 13:45-HR 107 BP 126/74 with worsening HA, persistent nausea.

Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5 1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet 1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps 1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen

Pt started feeling hot and tingly after getting your first series COVID-19 vaccine. lately started having hot flashes and tingly scratchy throat. Pt was administered 04 Epi pens (0.30 mg IM) and 01 Diphenhydramine (50MG IM L Deltoid). Pt was transported to Hospital via ambulance.

Reporter received the first COVID-19 vaccine on 12/30/2020 and waited the recommended 15 minutes for observation. After the observation period, she left the facility and started to notice tightness and what she describes as a "bubble" at the top of her throat. She also noticed a tingling sensation in the top of her lip, but did not notice any swelling. Reporter took 25 mg of liquid Benadryl and within an hour the sensation in her throat began to go away. Reporter received the second COVID-19 vaccine on 1/20/2021 at 08:25 AM. She had proactively taken diphenhydramine following the reaction to her first dose. Around 08:40 AM, she began to feel tightening in her throat and some heaviness in her chest. She was evaluated by a nurse who took her blood pressure (normal), however, her heart rate was elevated (noted this could be that she was nervous following initial reaction and repeat tightness in throat). Around 08:55AM, she began to feel like her tongue was swelling and that she had a "bubble" on the top of her throat. She was taken to the Emergency Department for evaluation. She was given hydroxyzine, famotidine, and dexamethasone in the ED and was discharged and felt stable. She reported a continued odd sensation in her throat the evening of the second vaccination. This feeling resolved the next day, and she reports no additional side effects from the vaccine.

Severe shaking about 12 hours after injection. Started as shivering and turned into full body convulsions lasting just over an hour. Bundling up in blankets did not help as shaking intensified. Only other side effect was a sore arm at injection site.

Very sore arm the following day (difficulty using and lifting) and tired. Then two days later work up with headache and nausea.

WOKEN UP BY SEVERE ARM PAIN APPROXIMATELY 12 HOURS AFTER INJECTION. PAIN DID NOT CHANGE ENTIRE NEXT DAY. SLIGHTLY BETTER SECOND DAY AFTER, HOWEVER I WENT TO WRING OUT A WASHCLOTH IN THE AFTERNOON AND EXPERIENCED EXTREME HORRIBLE PAIN THAT RADIATED IN MY LEFT WRIST. I HAVE NEVER FELT A PAIN LIKE THAT, I WAS AFRAID SOMETHING WAS REALLY WRONG. IT SLOWLY SUBSIDED, AND SINCE THEN I HAVE BEEN CAREFUL WITH HOW I USE MY WRIST AND ARM, BUT IT IS STILL SOMEWHAT PAINFUL AND DOESN'T FEEL RIGHT. I AM AFRAID I WILL FEEL THAT PAIN AGAIN IF I MOVE/PUSH/LIFT ANYTHING IN A CERTAIN WAY.

[Pfizer Covid-19 vaccine] treatment under Emergency Use Authorization(EUA):received the Pzifer COVID vaccine on 12/18/20 at 10:50. I began experiencing numbness and tingling from my knees to my toes 40 minutes following the vaccine in both legs. I am still experiencing tingling and numbness in my legs at times.

weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night. She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021. The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek4176) intramuscular on 12Jan2021 11:15 at single dose on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=Ej1685) intramuscular on 22Dec2020 at single dose on Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient experienced Fatigue, Body aches, Headache, Weakness on 13Jan2021 12:00 AM. The outcome was Recovering. No treatment received for the adverse event. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.

I had a fever in the middle of the night, but no pain at the injection site. On Monday, January 25 my arm and part of my back felt like they were burning/itching and were sensitive to clothing and clothing tags. Not anything major or that i'm too concerned about, but wanted to know if any others have experienced this as well. My skin isn't red and there's no rash- it is only hypersensitive to touch. I don't have any food allergies or any allergies to medicines. I've never had adverse reactions from a vaccination before and my skin is typically not sensitive to anything.

Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in their neck, and dizziness. Care was managed on-site by EMS and patient refused transport to hospital. Signed refusal of EMS transport states non-urgent acuity at time of discharge.

Vaccine was administered not even 1 finger width below shoulder. Bruising noted where vaccine was administered. Patient had feeling of shoulder area being 'asleep'.

Vertigo. Patient presented with lightheadedness and dizziness with associated body tremors. Symptoms started 5-10 minutes after patient received her 2nd Pfizer vaccine dose. Patient has h/o vertigo and reported vertigo, headache, nausea, and emesis following the first vaccine dose. Unsure if syncope 2/2 vaccine vs vaccine adminitration anxiety vs h/o vertigo. NS bolus, Benadryl, Ativan, Tylenol, and Motrin were given. Normal EKG. Symptoms improved and patient discharged from the ED.

arm soreness for 2 days after injection, lips swelling and numbness for couples hours on the second day after injection, consistent headache on second day, significantly decrease in breastmilk supply starting 2-3 days after injection and hasn't recovered (I'm breastfeeding my baby completely since birth in July 2020).

ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way through the fingers lasting for 2 hours.

My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .

Patient received Pfizer BioNTech on 12-23-20 & 1-13-21. She woke upon 1-21-21 with Left side Bell's palsy, She did go to the ER and report attached. She also reported a tennis ball size swollen lymph node in R underarm (armpit) on 1-14-21 for a day or two. very tender to touch.

Severe chills, fever -103, nausea, chest pain (felt like I had a bubble in the center of my chest), abdominal pain, body pain all over, weakness, loss of appetite, migraine Symptoms started yesterday and still ongoing. Taking ibuprofen

sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy than usual unsure if related.

Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigue

She immediately started having hot flashes after receiving vaccination, that have not resolved since time of patient reporting ADR on 1/14/21 (~12 days in duration). She also experienced a bad headache with blood vessel rupturing in her eyes.

Dizziness, Flushing Denies trouble breathing. Escorted to stretcher to lie down. BP 157/88, HR 98 RA 100%. Snack/juice given. BP rechecked 130/84 and HR 86.

Headache started 20-30 minutes after administration, off and on the last 24 hours. Sore left arm with pain in armpit/lymph node area. Tingling pain down to left elbow and hand. Sore back and shoulder. Chills throughout night sleeping and into next night

Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (19:00) (Lot number: EH9899; Expiration date was not reported), and then the second dose on 12Jan2021 (18:45) (Lot number: EK4176; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, after the first dose of vaccination, the patient had a headache/headache that felt like migraine. The patient had experienced a similar headache (headache that felt like migraine) on 17Jan2021, after the second dose of vaccination. The patient had received bultalbital, acetaminophen, caffeine (FIORICET) as treatment for the events. The outcome of the events, headache/headache that felt like migraine, was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.

Sore arm (and got really red; tender and really swollen) and body aches and muscles aches; slight fever; severe headache and chills -counted get warm - lasted about 48 hours. But my arm was really sore for another 2 days after all the other symptoms cleared. Treated with Tylenol around the clock throughout.

This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date not reported), via an unspecified route of administration in the left deltoid on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis from 2009 and exposure to a positive COVID patient on 08Jan2021. The patient also had a sinus drainage down the back of her throat. It went away but started back up on 09Jan2021. It is the same since last night but had improved from over the weekend. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) on 21Dec2020 at single dose for COVID-19 immunisation. The patient had her second COVID19 Vaccine dose last Saturday and reported having a "weird reaction". She had already gone to urgent care and was told to call. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist), which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Patient said that she was not sure if she was having a reaction or not to the Pfizer COVID Vaccine. She was just in urgent care that morning and was going to primary care that afternoon. Urgent care thought she was having a reaction. She got her second dose of the vaccine on Saturday morning, 09Jan2021. That night she had the typical immune response. She had chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure, which lasted through Sunday. She took Sudafed PE and Monday when she woke up, she felt normal. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist, fingers, feet, face, upper arms), rash which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Benadryl helped it get better, but after it wears off the rash comes back and it gets worse. It had spread to different areas. Sometimes, it will be really bad on her knees, then other times really bad on her elbows or hips. Her hips were bad last night. Now it is on the bottom of her feet and on her knees again. She asked if these were something that have been previously reported. All of these symptoms, besides the rash, she felt like she had the flu. It knocked her on her ass it was pretty terrible. But it went away and she felt better. It was a typical immune response so she would say it was not serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. Clinical outcome of events chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure was recovered on 11Jan2021, while for the other events was not recovered.

Within 24 hours after administration of 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA, patient began experiencing tingling and numbness in hands and feet, weakness, fatigue, muscle and joint pain, chills, fever of 100.4 F, headache, and nausea, in that order developing over the next 48 hours.

high fever 102.6, severe body aches, chills,sweats, headache, neck pain,weakness, fatigue, nausea, runny nose, 48 hrs and going

Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye pain when looking at light

supraclavicular painless lymphadenopathy noted ~ 1 week after first injection. lymphadenopathy was on same side that injection was delivered to. after second dose, lymphadenopathy became slightly tender to palpation and noted additional palpable lymph node next to first one. three weeks after second dose, lymph nodes still palpable but smaller and nontender.

10:30am- 2nd dose received 1:30pm -fatigued/ headache (Advil taken, symptoms subside) 6pm - fatigue/ sore arm/ headache (Tylenol, symptoms worsen) 11:30pm- chills, body/ muscle aches, clammy 1:30pm- worsening chills, worsening aches, insomnia, restless legs, panic attack 5am- nausea, aches, chills, fever (Tylenol & Zofran- helped minimally) continued lack of appetite Symptoms subside Approx 48 hrs after 2nd dose.

Had a low fever of 99.9 throughout the day, chills, severe headache, joint pain and weakness, dizziness, nausea.

Pfizer COVID-19 Vaccine EUA Event Description: Felt light headed and slight numbness in tongue and throat about 10 minutes post Covid-19 vaccine (Pfizer EL9261, exp. 5/1/21). History of vasovagal reactions. Also said numb tongue made her think of trouble swallowing. Given water, Benadryl 25mg PO, Zyrtec 10mg PO, and Famotadine 20mg PO and felt better. Heart: RRR without mrg Lungs: clear Skin: blotchy and slightly flushed in spots Throat clear No problems swallowing medications, also given Ginger Ale

On 12/30 I developed neck pain, a headache, chill and shaking but no fever, diarrhea, ear pain and nasal congestion. I had a virtual visit with the NP and was advised if the symptoms got worse to take tylenol and ibprophen. I was advised I could take mucinex and recommended a COVID test. It was performed on 12/31 which was negative so I took mucinex for the congestion and after 2 or 3 days I began to feel better.

nausea vomiting and painful flush feeling in chest and extremes. improved after vomiting but nausea and flush feeling persisted for 3 hours

Bell's Palsy. Symptoms include right sided facial weakness, eye drooping. Onset was around 12:30 on 1/28. Went to walk in clinic where MD confirmed Bell's Palsy and prescribed Valacyclovir and Prednisone. Started medications around 5pm on 1/28.

Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization. Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship. Of note, the patient has a medical history of seizure disorder. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

28 yo F here at 30mdg for covid vaccine. pt with h/o "anaphylaxis with other shots." Pt notes had facial/nose/lip tingling with prior vaccines, requiring steroids and oral Benadryl. Patient received the covid vaccine at approx 1715 on 21 Jan 2021. At approx 15 minutes, pt developed numbness and tingling to her nose and lips. pt notified Rapid Response Team, who notified Physician. monitored patient for 5-7 min, pt noted that her symptoms were worsening, to include numbness and tingling affecting most of her face, cheeks, lips and nose. No trouble breathing. no lip swelling or tongue swelling. HR 78. Gave oral benadryl - gave her 4 ml of po benadryl (12.5 mg/5ml) at approx 1735, and another 4 ml po benadryl (12.5 mg/5ml) at approx 1740. pt prefers to be treated with steroids because a similar previous episode resolved with benadryl and steroids. pt symptoms persisted with facial numbness and tingling ... and subjectively were worsening. no coughing, no tongue swelling. no lip swelling. no shortness of breath. FM physician arrived - prepped for 60 mg im solumedrol. at approx 1750, FM physician gave IM Solu-Medrol in R shoulder. pt waited for approx 15 min - felt better. numbness and tingling of face and nose were lessening, almost gone - only tip of nose was affected. no facial swelling. no lip or tongue swelling. no trouble breathing. no shortness of breath. physician gave return parameters - benadryl prn overnight called patient the following monday - stated she slept that night (from benadryl), felt better the next day. no further concerns

Hypotension; fever; chills; body aches; severe arm soreness/tenderness; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received second single dose BNT162B2 (Solution for injection, lot number: EL3248, exp date not reported), intramuscular (vaccine location: left arm) on 12Jan2021 10:30 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took first single dose of BNT162B2, lot number: EL1284, intramuscular (vaccine location: left arm) on 23Dec2020 23:00 for COVID-19 immunization. On 12Jan2021 23:00, the patient experienced hypotension, fever, chills, body aches, and severe arm soreness/tenderness. The events were considered as non-serious by the reporter. No treatment was given for the adverse events. On 20Jan2021 Nasal Swab was negative. The patient recovered from the events on Jan2021.

Rash (scaly spots appeared over the left upper extremity and back - this isn't an uncommon autoimmune response for this patient) Brain fog Word finding difficulties Suspected decreased seizure threshold - unclear if partial seizure was elicited Intense fatigue Increased sleep Treatment: monitored for 30 minutes status post vaccine injection without any notable concerns; routine observation and monitoring given seizure history Time course: Rash lasted for 1 week; Brain fog/word finding difficulties last fully for 10 days, then started to dissipate; Fatigue and increased sleep lasted 1 week

body aches; chills; sweats; migraine; light sensitivity; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on left arm on 20Jan2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not allergic to medications, foods, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and multivitamin. The patient was not pregnant at the time of vaccination. The vaccine was administered at the patient's workplace clinic. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches, chills, sweats, migraine, and light sensitivity, all on 21Jan2021 at 09:00. She did not receive any treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.

post covid vaccine symptoms included, fatigue, lightheadedness, cold sweats, brain fog, severe neck and back aches.

After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue, arm soreness for 2 days. Appendicitis resulting in appendectomy 4 days later

In the evening had chills, shaking, could not get warm, low grade fever, 01/13/2021next day all over body aches, 99.9 and then arm pain at injection site nausea and diarrhea 01/14/2021 nausea and diarrhea disappeared on 01/14 or 01/15/2021. Nausea and diarrhea with first dose for two days.

Sore arm for 3 days, headaches same day until current, chills same day to current, dizziness same day till current, fatigue, diarrhea increased heart rate

3:00pm headache 10:30pm start of fever 101.8 followed by intense body aches all over the body but worse in the lower extremities. Cold chills developed as well with mild to moderate body shaking. Symptoms lasted for 18 hours before totally stopping.

Episode of palpitations and tachycardia to the 120s the night of my shot. Took my PRN Propanelol 20mg with resolution. Arm soreness x2-3 days

6pm: body aches, feeling cold, not hungry or able to finish my dinner, drowsy. I went to bed around 7pm. All that night, I was hot and sweating and freezing cold. I had a lot of pain in my lower back and would have to position myself in fetal position. There was no position that felt comfortable. 24 hours after the shot, still fatigue, stayed in bed for most of the day. No appetite. 48 hours: limited appetite, I was hungry, but when eating just felt bloated and not interested. Would feel stomach aches if I attempted to eat more. The monday following the vaccine, I had eaten lunch and noticed I had a burning feeling in a lower area of my throat. My stomach felt slightly upset.

Chills were the first symptom. The next day, I also experienced feeling very cold and some chills. I passed out briefly after getting out of bed and threw up right after that. I had body aches. I was nauseous but was able to take ibuprofen in the late morning. After the ibuprofen wore off, my body aches returned as well as a lethargic feeling. The next morning, I experienced nausea again until in the afternoon.

Fatigue and mild headache starting 24 hours after the injection. Approximately 30 hours after injection, headache progressed to severe headache with migraine features (sensitivity to sound and light) Symptoms resolved within 48 hours.

Itchy throat; left side of face burning; left side of face burning/tingling sensation; burning/tingling sensation left side of lip; burning/tingling sensation and left side of lip; This is a spontaneous report from a contactable other healthcare professional. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL3302) on 21Jan2021 17:00 at single dose on right arm for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: E11284, on 29Dec2020 13:30 on right arm. Medical history included asthma and seasonal allergies. The patient did not test for COVID post vaccination. The patient is not pregnant. The patient experienced itchy throat, left side of face burning/tingling sensation and left side of lip on 21Jan2021 17:45. The patient took Benadryl as treatment for the events. The outcome of the events was recovering.

Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her body, all muscles felt heavy and weak; could not control her body, all muscles felt heavy and weak; Felt tingles in feet and lower legs; This is a spontaneous report from a contactable consumer(patient). The 28-year-old female patient(not pregnant) received first dose BNT162B2(COVID 19, lot number: EL9262), via an unspecified route of administration at left arm on 22Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included none. She had no known allergies. Concomitant medication included spironolactone, amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin b complex (VITAMIN B), ergocalciferol (VIT D), ZINC, omeg(omeprazole). There was no other vaccine in four weeks. About 11 hours after receiving(23Jan2021), she very quickly became disoriented and weak, could not control her body, all muscles felt heavy and weak. She fell once and then presumably passed out - she came to after falling again. She felt tingles in feet and lower legs. After sleeping about 9 hours, she felt better. There was no treatment received, no covid prior vaccination, covid tested post vaccination. Events were assessed as non-serious. Outcome of events was recovering.

Usual tiredness & adverse effect on PRN medication. I take sumatriptan for onset of migraine attacks. Ever since I received the 1st dose on 1/22/21, when I take this medication, my face starts to itch & has a tingling sensation (pins & needles feeling). I have been taking this medication for 10yrs & not once have I ever had this kind of reaction. I am a little scared.

itching rash, tingling and warming sensation in arm radiating down within 15 min of shot. Pt has history of several allergic reactions to foods and medications. Stated that this felt like a similar reaction. Provided OTC Benadryl and patient stated that it resolved fairly quickly after initial dose, but had to continue w/ Benadryl for 2 days afterwards otherwise rash would reemerge.

She felt panicky prior to injection. Felt flush and panicky after injection. Had ginger-ale and ice pack to help with flushing. Left injection room approximately 35 minutes post-injection. When walking down the hall, she said she started to feel more panicky and felt paresthesias near lower jaw--stated she doesn't normally feel that way during a panic attack. Physical assessment normal. Vitals signs normal. Dexamethasone 4mg IM given. Paresthesias stopped about 10 minutes after dexamethasone. Went home and stated all had resolved by the time she got home and nothing has happened since.

Left side of body felt very warm and felt like it was melting; red rash on left side face, neck, chest, arm; Facial spasms; Fever; Confusion/lightheaded; Confusion/lightheaded; Palpitations; Feeling of being unwell; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm single dose for COVID-19 immunization on 22Jan2021, 05:45 PM, at 28-year-old. Medical history included: COVID-19. No allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included: daily vitamins, lisdexamfetamine mesilate (VYVANSE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient left side of body felt very warm and felt like it was melting. The patient had red rash on left side face, neck, chest, arm. The patient had facial spasms, fever, confusion/lightheaded, palpitations, feeling of being unwell, fatigue. All on 22Jan2021, 06:45 PM, and was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit, no treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving. Information on the lot/batch number has been requested.

fever; migraines; Chills; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient (Weight: 150 lbs, Height: 5'10) received first dose bnt162b2 (Batch Number: EL3248, expiry date: Apr2021), via an unspecified route of administration on 22Jan2021 at single dose for covid-19 immunization. Medical history included ongoing migraines. The patient's concomitant medications were not reported. The patient experienced chills in Jan2021, fever on 23Jan2021, migraines in Jan2021. Developed low grade fever (100.8) and chills after receiving the first dose of the Covid-19 vaccine. First does giving 22Jan2021. Fever started late evening 23Jan2021. Developed migraine approximately 6 hours after the shot. The patient underwent lab tests and procedures which included body temperature: low grade fever (100.8) an unspecified date. The outcome of events was unknown. No follow up attempts are possible. No further information is expected.

About twelve hours after getting the vaccine I got a fever which is fine and expected but then my whole body started shaking. It has not stopped. I s not painful but making it hard to do my job

After my 2nd dose administration, I sat in an observation tent with 4 resident doctors. This is protocol at my hospital to assess for any adverse reactios. About 10 minutes later, I started to feel both of my arms (from should all the way to tips of my fingers) start to get tingly with an intense vibrating sensation. I tried to calm myself down, however numbness began to occur to both BUE seconds after. Next thing that happened, bilateral fingers became visually contracted however numb and I could not move my fingers. I also got a tingly/prickly sensation to my cheeks all the way down to my chin after the hand numbess. The resident doctors quickly took me by wheelchair to a private room where they checked my vital signs. BP was elevated with systolic in 190's, HR around 120s, and my limbs were all cold. By this time it was around 6pm and they were trying to calm me down as I started to have a panic attack. My parents came to pick me up at 7pm when my vitals were stable. I rested at home, and the contraction to my fingers/numbess did not subside until 8:30pm. The following day, my left arm (injection site) had a soreness level of 9/10. Tylenol was used to relieve pain.

Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; could not regulate my temperature; fluctuated between being diaphoretic and cold to being overheated; fluctuated between being diaphoretic and cold to being overheated; fluctuated between being diaphoretic and cold to being overheated; I did experience an episode of nearly passing out sometime during the night; Fatigue throughout the day increased.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 28-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included SLE (systemic lupus erythematosus), asthma (mild), PTSD (post-traumatic stress disorder), anxiety, ADHD (attention deficit hyperactivity disorder), allergy to egg whites, allergy to bee stings and diagnosed with COVID-19 prior to vaccination. Concomitant medication included desvenlafaxine succinate (PRISTIQ), methylphenidate, hydroxychloroquine sulfate (PLAQUENIL), clonidine received within 2 weeks. The patient previously took escitalopram oxalate (LEXAPRO) and experienced Allergy to lexapro, sertraline hydrochloride (ZOLOFT) and experienced Allergy to Zoloft, quetiapine fumarate (SEROQUEL) and experienced Allergy to seroquel, erythromycin and experienced Allergy to erythromycin. On 28Jan2021, the patient experienced fatigue throughout the day increased. The patient developed headache. Awoke around 28Jan2021 23:00 with aches, chills, severe headache, weakness, dizziness, and nausea. She did not feel she could move safely to retrieve OTC medications for these symptoms which were far worse than any illness she can recall having. She likely would have went to the ER for help but she couldn't have driven herself and her kids were home. She did not want to call 911. On 28Jan2021 23:00, she did experience an episode of nearly passing out sometime during the night when she attempted to sit up on the edge of the bed to take some Tylenol. She could not regulate her temperature as she fluctuated between being diaphoretic and cold to being overheated. In the morning she finally felt well enough to go to her medicine cabinet downstairs and decided to essentially sedate herself for the day with Benadryl, Xanax, zofran, Tylenol, and ibuprofen. She then slept from about 10am until about 5pm. She felt considerably better upon waking up, with just fatigue, nausea, and headache. The report was reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events fatigue, nausea and headache was not resolved and the outcome of the other events was resolving. Information on the lot/batch number has been requested

Blindness (loss of vision); Neurocardiogenic syncope; Tingling in hands and feet/lower legs; Panic attack/unable to breathe; Nausea; Vomiting; Dehydration; Tiredness; Body aches

Extreme fatigue; headache; heart was racing; nausea; diarrhea and body aches. These lasted until 06:00 AM the next day. A little headache and arm soreness still that next day - by noon that day I was feeling myself again.. I took ibuprofen for the headache and that helped.

Headache 5am, hurts to lift head or move neck; Nauseous since 1am; Chills since 1am; All over muscle aches and pains 530 am; Fever 100.4/feeling feverish 6am; Shaking/shivering since 3am

L arm, some numbness and tingling, "tongue feeling fat", toes tingling". Patient was taken to triage, tongue and oral membranes assessed, no signs of swelling, lungs clear, v.s. taken, patient given 25mg of benedryl IM., patient also given orange juice, continued to monitor for 30 minutes, symptoms subsided. Patient was walked out and driven home by her co-worker.

stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested.

tingling and numbness in hands and feet; tingling and numbness in hands and feet; weakness; fatigue; muscle and joint pain; muscle and joint pain; chills; fever of 100.4 F; headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 26Jan2021 18:00 at a single dose on the left arm for COVID-19 immunization. Medical history included asthma, fibromyalgia, ADHD, GERD, IBS, and allergies to pollen and yellow onions. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), diltiazem, and topiramate. Patient is not pregnant at the time of vaccination. The patient received the first dose of bnt162b2 on 05Jan2021 15:00 (lot number: EL1284) on the left arm. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 post-vaccination: Tempus iC SARS-CoV-2 RT-PCR on 28Jan2021 with result negative. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 14:00, within 24 hours after administration of second dose, patient began experiencing tingling and numbness in hands and feet, weakness, fatigue, muscle and joint pain, chills, fever of 100.4 F, headache, and nausea, in that order developing over the next 48 hours. Patient has not recovered from the events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes Tylenol. Events reported as non-serious.

Evening of the vaccine, Sunday, had left arm soreness, and vomited that night. I woke up Monday morning with a fever of 101.6, extreme fatigue, nausea, vomiting, aches and pains and chills. Monday went to get a COVID nasal swab test as required by my work-place, was negative. Tuesday, I had continued nausea, fatigue, chills, fever of 99-100. Went to see Healthcare Professional, they ran labs (detailed below), only found low eosinophils, and leukopenia. Received nausea medication. Was able to eat on Wednesday, severely fatigued Wednesday, temperature remained 99-100. Thursday had major fatigue, headache, nausea. Was feeling better on Friday.

Fever (99.7 degrees F), chills, muscle aches, joint aches, severe dizziness, significant fatigue, severe migraine. All symptoms started at 4:00 am 2/13 and were present throughout the entire day 2/13. Migraine and dizziness persisted until 2/15 but lessened in intensity each day. managed symptoms with Aleve

Pfizer-BioNTech COVID-19 Vaccine EUA injected into left arm at 10:15 am on 17 Feb. Soreness at the injection site was the only symptom immediately following the injection. At about 3:00 am the next morning, I experienced extreme nausea and chills. I fainted when I tried to get out of bed to go to the restroom. All of 18 Feb, I experienced the following symptoms: headache/migraine, fatigue, dizziness, loss of appetite, muscle aches/soreness, fever, and severe pain in my left arm. As of today, 19 Feb, I am experiencing headache, lightheadedness, and mild pain my left arm.

Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue

About 30 hours following injection, observed slow to full facial pain on the right side of face and head. Face was mildly inflamed and in pain for approximately 6 hours, then gradually the pain and inflammation subsided. No ibuprofen or other pain relievers were taken at the near the time of adverse event. Ibuprofen (400 mg) was taken at approximately 9 pm the previous evening to reduce arm pain/pain at the injection site.

Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered, No EMS, resolved during extended observation.

Pain began as a "crick" in the left side of the neck two days after receipt of second covid vaccine. It has now been three weeks and pain has been continuous in the left shoulder and left neck. Pain radiates down the arm and up into the ear, making the ear hurt and making it painful to swallow. The skin is also tender/painful to touch in the same areas, as if nerve damage has occurred. Swelling is visible in the upper back and neck.

Sore arm/arm felt sore; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: EL3247), via intramuscular route of administration, on 26Jan2021 10:15 AM (at the age of 28 years old) as a single dose in the left arm for COVID-19 immunization at work clinic. Relevant medical history were anxiety, depression. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), aripiprazole (ABILIFY), iron, ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 04:00 PM, the patient experienced sore arm/arm felt sore. No treatment was received for the event arm/arm felt sore. The outcome of the event arm/arm felt sore was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Walking around house doing chores after working from 9-6 with 90 minute lunch break as a dental hygienist. Could feel left foot start to go numb and tingling and feel very cold. Took thin sock off foot, pinky toe was purple. Took pictures. Could not get foot to warm up with warm/hot compresses. Started having slight discomfort in lower back/butt with pain going down leg to toe within the hour. I believe this could be coincidence and have sciatic pain, but thought I should report just in case there are few other reported cases on this. Purple discoloration was gone when woke in morning on 2/23/2021 It is now 2/24/2021 and I am still having sciatic pain and numb pinky toe.

Ballspalsy, right side Eye and facial movement issues, it started gradually a week and a half after my dose my eye was not blinking in sync with my left eye, gradually started to go down to my face where my lips my cheek or my eyebrows were not moving when I was talking all my words were slurred and off to the side of my mouth. When smiling one side trip the far far left the other side stay still. My job had me go to a doctors up where they diagnosed me with Bell?s palsy it and the doctor advised me to report this. My treatment plan is antiviral medication and steroids, Valacyclovir 1gm tid, methylprednisolone 4grams qid. I am very upset and heartbroken every time I look in the mirror I cry because I cannot recognize my face I did read online that Pfizer did have side effects of bells palsy but I never thought I would get it given my age and good medical history. I would love for someone to reach out to me I need to know what happens from here. As a result I have been off of work for a couple days.

3-5 minutes after receiving the vaccine, I felt a sense of panic and a tingling on my lips, that then spread to my mouth, throat, and tongue. I asked the nurse if my lips were swollen, and she said no. A few minutes later my heart rate increased and I felt really lightheaded. After 7-10 minutes I felt my tongue tingling and it had become swollen. I told the nurse that I think my tongue was swollen and she said it looked okay. I had a hard time talking because I wasn't used to be tongue being so large. The nurses stayed and talked to me for the rest of the 30 minute waiting period. I was able to talk and breath while making a conscious effort. I wasn't sure whether the high heart rate and lightheadedness were associated with my condition, Postural Orthostatic Tachycardia Syndrome. I kept checking my tongue to see how swollen it was. After the 30 minutes, the nurses had me stand up to see if I could. Once I could, they said I was all set to go. They did not get an Epi-pen for the swollen tongue or give me instructions on how to treat it. They were insensitive and dismissive of my symptoms. they kept repeating "I think your just nervous." Once I got home, I still had the swollen tongue and tingling, but was able to go up and down stairs and go about my day. It was a little difficult to swallow one of my pills when I got home, but I was able to. I checked my blood pressure around 4:30 p.m. and it was 121/84 and my pulse was 79 bpm sitting. I did not take anything to treat my swollen tongue. The swollen tongue and tingling feeling in my throat continued for another 2.5 hours, until 6:00 p.m. Once the swelling was down, my tongue felt like I burnt it on a hot beverage, almost a numb feeling. I also experienced more common side effects such as body aches, fatigue, and feeling feverish. After this episode I had extremely high anxiety where it was difficult for me to sleep the following night. I called a 24/7 nurse line and she said to talk to my doctor. I had less than 4 hours sleep the night after I had my vaccine. I called my doctor's office this morning and I spoke to a nurse who worked as a nurse on the COVID Vaccine hotline. She relayed the message to the doctor who was covering for my doctor while she's on medical leave. I received a call around 9:30 a.m. saying that the doctor on leave recommend I should talk to my PCP but that she thought I had an allergic reaction to the Pfizer vaccine and that I should not get the second dose. She said they were not sure how I would react with the second dose, and they're afraid that my allergic response might be more severe and life threatening. I hope this report helps other people who experience these symptoms.

Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes left armpit; tingling left wrist; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el9261) via an unspecified route of administration on the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included drospirenone, ethinylestradiol (NIKKI) for birth control. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (lot number: ej1685, left arm, 02:00 PM). On 26Jan2021 04:00 AM, the patient experienced fever, chills, Muscle aches, swollen painful lymph nodes left armpit, tingling left wrist, headache, fatigue. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Post vaccination, the patient has been tested for COVID-19, nasal swab on 25Jan2021: pending result. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. Outcome of the events was not recovered.

Extreme armpit pain/breast pain on side of the injection that lasted 3 days. Lymph nodes were able to be palpated and a bit swollen.

Migraine lasting for 10 hours, vomiting, diarrhea, nausea, chills. Took ibuprofen, stayed in bed. Still have nausea and migraine today. Tested positive for Covid 03/01/2021. Also had Covid 11/19/2021

Pfizer-BioNTech COVID-19 Vaccine: Thirty minutes after receiving vaccination developed trunk flushing, nausea, and tiredness. Flushing quickly resolved but patient reports nausea, abdominal pain, mild headache, and tremors since vaccination. Six days after vaccination noticed hip bruising in the absence of falls or trauma and a cut on the hand that bled more than expected. No respiratory distress or rash noted on exam. Vital signs all within normal ranges. Patient left clinic visit stable and advised to avoid non-steroidal anti-inflammatory medications.

Patient was seated during her mandatory 30 minute wait, where she stated she began to feel light headed and had a headache. Stated that she has a history of pseudo seizures and that she had one with her first vaccine. Patient then became unresponsive, slumped back in her chair and began to seize. She was lowered to the floor while she was seizing and monitored by paramedics who were on site until the seizure was over. The seizure lasted approximately 4 minutes. Patient was postictal and elected to be transported to the ED for further evaluation. ED discharged her home.

"the next day [after vaccination] the injection site was extremely sore and the pain went up to my neck and down into my hand. From what I heard this is pretty normal so I had no concerns. Over the next couple days the injection site pain was gone along with the neck pain but the wrist/hand pain persisted. It?s now been a week since the pain started and my wrist/hand/forearm are still really sore/achy. I?ve been icing it multiple times a day but the pain persists. It?s especially bad when typing or doing any repetitive motions with my hand. "

5 hours post vaccine- sore arm, low grade fever, 12 hours post vaccine cold symptoms (stuffy nose, sneezing, coughing), 24 hours post (severe cold symptoms listed above, fever, body aches). Also- I'm pregnant (5 weeks).

Right after vaccine injection, patient started having tingling in her face and feeling sob. Episode last about 5 mins. Afterwards, pt felt fine. Denies chest pain, rash, itching or dizzy. RR 18 BP 120/73 HR 74 and oxygenation of 99%.

I am breast feeding an d I got mastitis from a breast duct. I was put on a 14 day Clindamycin. My doctor did not think this was related to the vaccine but that I had to report it. I had chills and breast pain and pain at the plugged duct. I saw my doctor through telemedicine.

Pt mother states that Pt is having a panic attack, pt verbal, but kept repeating that her hands were numb, seated and agitated. Evaluated by EMS-Cleared

Muscle aches (back); Injection site pain; Headache; Flushing in face; Brain fog; This is a spontaneous report from a contactable other hcp (reporting for herself) A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration single dose on 06Feb2021 10:15 (at the age of 28) left arm for covid-19 immunisation. The first dose (lot# EL12849) was taken on 15Jan2021 10:15 am, left arm. The patient medical history was not reported. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced muscle aches on 06Feb2021 19:00, injection site pain on 06Feb2021 19:00, headache on 06Feb2021 19:00, flushing in face on 06Feb2021 19:00, brain fog on 06Feb2021 19:00. No treatment received. The events outcome was not recovered.

Est DD: 08/07/2021 Patient reported feeling hot and light headed within 5 minutes of receiving injection. Assisted into on the cot. Reports feeling shaky and anxious. States worried because of being pregnant, nausea as well. 1240 BP 147/89 HR Spo2 99% 1245 BP 126/86 HR 104 Spo2 100% 1255 BP 142/87 HR 96 Spo2 99% ( edge of bed) 1305 All symptoms have subsided. Standing on side of bed. 1310 No further issues . Accompanied out by family member.

Metallic taste in mouth, then following with numbness, tightening, and tingling in throat and mouth. First treated with Benadryl, then decadron and Pepcid. After reaction did not stop, I was taken to the ER and given IV steroid(s). On discharge I was given epinephrine and prednisone. This occurred over a four hour period.

Shortly after receiving the shot at work, I developed worsening dizziness as well as a headache and internal tremors, which resolved. I later developed generalized itching, worse on the back of my hands and feet, which resolved. The following day, I developed palpitations while at rest and mild shortness of breath. I also had a brief bout of nausea, which resolved, but I still have palpitations and mild shortness of breath.

Client stated that she had prior history of vaso-vagal response to vaccinations, finger pricks and blood draws, that usually they have her lay down when she gets shots. She also has had nausea and dizziness after other shots. She felt nauseous within 2 minutes and was pale and faint, weak. Checked her bp was between 100/60 and 120/80 pulses 40-60. she was"passing out" between answering questions, called EMS and asked her about what she had eaten this morning. she stated some of a bagel but not all. F/U on 3/12 states she felt better with normal BP/pulse while in ambulance and the EMS released her with out transfer, she sat in her vehicle for 1 hour before driving home. she felt weak with sore shoulder on 3/11

Large red raised area at injection site, warm to the touch. Fever of 99.8, muscle and body aches, fatigue, migraine, un-productive coughing, chest tightness, difficulty breathing.

First dose: Had a very slightly sore arm a few hours after injection through the following morning. Then had a very slight headache for a couple hours. Then the day after that my neck was very sore on the side the vaccine was given. I watched TV on my laptop and had my elbows on my thighs for maybe 30 minutes and I often watch TV like this. When I went to the bathroom, I saw my thighs had multiple bruises where my elbows were (3 spots) while I was watching TV. The bruises and sore neck lasted another 2 days and I was fatigued more quickly during this time. After that I was fine, though 1 bruise spot still remains today 11 days after vaccination. The easy bruising and lasting bruising is not normal for me. I have dark color skin and also rarely bruise.

Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unknown number), Nausea, Dizziness, Unable to stabilize quickly, not able to get an IV, extreme thirst Signs: Immediately felt unwell within 5 minutes of the vaccine. Time Course: Injection (1st dose - Pfizer) at 4:00pm. Adverse Reaction at 4:05/4:10 (est.) Released at 5:00pm (est.) Description of Incident: On March 8th, at 4:00 pm, I received my first dose of the covid vaccine. Within 5 to 7 minutes, I felt unwell while sitting in the waiting area. I walked towards a worker to inform them that I was feeling unwell and that I was going to pass out. I became unresponsive and laid on the ground. My husband was with me at the time. I was unconscious for a bit and when I regained consciousness, my legs were being raised. I regained consciousness and was able to recall my name, DOB, and address. After I was done recalling my information, I began to lose consciousness again. They brought a wheelchair and took me to the medical room. As I moved from the wheelchair to the bed, I began to lose consciousness again. They told me to lay down. I overheard a woman ask my husband if I had diabetes or heart problems. He answered ?No.?. She explained to him that my body did not know how to accept the vaccine and was trying to regulate back to normal. She explained that my body was going through ?homeostasis? (?). While I laid on the bed, some workers took my blood pressure and tried to start an IV. One of them made a comment and said I was extremely dehydrated. This was odd to hear because I normally drink 3 to 4 liters of water daily. During this entire medical event, I felt the water pushing out through my pores. I was drenched in sweat. He tried to start an IV on my left arm and was unsuccessful. He tried to start an IV on my right hand, which was also unsuccessful. He stated they were unable to start IV liquids because my veins kept popping/collapsing. My blood pressure was reading 60. They checked it again, still at 60. I laid in the bed and basically waited it out. After a few minutes, they checked my blood pressure at it was at 120. They said that was good and I was good to go. No report was given to me nor my husband about the event that occurred. Even after they agreed to let me use a wheelchair (due to feeling weak), one was not provided to me. They basically stated that I was ?good to go?, after doing a series of hand squeezes and walking a few steps upright. I am currently trying to obtain a copy of the report I saw the gentleman fill out at the time. I was given Zofran to help with my nausea, it was placed under my tongue. After going home, I felt weak, tired and somewhat lightheaded. My husband drove me home and I got some rest. I set an appointment with my doctor on Friday March 12th to determine what happened to me during my vaccine and to record the incident. After describing the incident, she determined that it was anaphylaxis. She recommended for me not to get my second dose due to the anaphylactic shock I experienced with the first dose. She was shocked to learn that they did not transport me to the hospital or provided an Epi Pen injection. When asked why I didn?t drive myself to the hospital, I let her know that they told me I was ?good?. They did not explain what had occurred to me, no mention of anaphylaxis was explained. I was not aware that is what had occurred. The incident occurred from 4:00pm (injection time) to 5:00pm (left location).

Strong pain in deltoid muscle beginning the evening of the first injection (3/12) and the day after (3/13). Impossible to sleep on that arm, difficult to lift arm, severe pain when touched. Diminished pain 3/14-3/15.

Progress Notes Expand AllCollapse All Patient: DOB: 9/4/1992 Date: 3/12/2021 MRN: Subjective Patient is a 28 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling faint and hot. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , collapse, hypotension, rapid progression of symptoms and skin changes. Past Medical History: Diagnosis Date ? Acne ? Acute gastritis ? ADD (attention deficit disorder) ? Allergy ? Anxiety ? Depression ? Migraines ? Shingles 2017 ? Wears glasses in the past ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, vomiting, abdominal pain, dizziness and headaches Previous Reactions: She reports hx of fainting with vaccines in the past. She didn't have problem with 1st dose of Pfizer. Today she is here for 2nd dose. Objective Vitals Vitals: 03/12/21 1437 03/12/21 1450 BP: 115/70 124/64 Pulse: 70 76 SpO2: 98% 100% Physical Exam Constitutional: Appearance: She is obese. She is diaphoretic. Comments: flushed HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is moist. Neurological: General: No focal deficit present. Mental Status: She is alert, oriented to person, place, and time and easily aroused. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. Pt wheel chaired to the medical bay. Pt given ice packs x 2 and brought to the bed and placed in trendelenburg position. Pt vs taken and is stable. Pt feels better in this position. Slowly inclined to sitting position. Tolerating well. Skin dry. Assessment/Plan Treatment included: water, snacks and ice packs Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) She reports having improvement of symptoms after observation in medical bay for 40 mins. She is to be taken home by dad who was able to come in to pick her up. Pt wheeled to front by this provider and able to stand and walk w/o assistance to car. Monitor symptoms at home and follow up with pcp as needed.

day after vaccine, expereinced severe cramping and menstrual bleeding very heavily. I was two weeks before my period which is VERY abnormal. lasted for five days

I tested positive for COVID-19 on 12/16/20. I got my first shot (Moderna) on 1/28/21. The next day my right arm and my whole body hurt. After 24 hrs, I went back to normal. On 2/4/21, I went back to get my second dose of (Moderna). I didn't know I was not suppose to go 28 days later, since i only remember them telling me to go back on a Thursday at 3:30 PM. I gave my vaccine card to a lady in the registration table. She did not see my name on their roster, therefore she wrote my name on the bottom of her sheet. She then asked the pharmacist "Do you have a spot for one more?". I went and he asked me on which arm do I want the vaccine and I said the "right arm". I don't remember him telling me which vaccine I was going to receive. He told me to wait outside in my car for 15 minutes. The next day both of my arms started feeling numb. I noticed that I received both vaccines (Moderna and Pfizer), when one of my coworkers asked me if I was ready to go and take the second dose on 2/22/21. That was when I checked my card and saw that I received both vaccines and my date for my second dose was on the back of my card 2/25/21. I called where I got the shot, and they said that they were not with the people in charge of giving the vaccines. I told my coworker to give them my number and tell them my situation, when she went to get her second dose (2/25/21). I never received a call from them. Staff from vaccine provider called me on 3/8/2021 to see if I wanted to schedule my second dose of Moderna. I had to explained my situation with her, since she did not know about it. She told me to go to my Family Doctor. I went to see him on 3/10/21. He said I will be ok and the symptoms will go away. He told me to take Claritin. I feel both of my arms less numb as of today. I hope this goes away soon. Other than that I feel healthy.

I was 33 weeks and 7 days pregnant on the date of shot, estimated due date 4/24/21, previous pregnancy delivered preterm at 34 weeks and 3 days due to preeclampsia, currently no indication of preeclampsia in this pregnancy Approximately 15 minutes after receiving the vaccine the right side of my face begin to tingle. It tingled off and on for the rest of the evening and in the morning the right side of my face was noticeably swollen for the first 3-4 hours of the day. It went away and I took no medication and have experienced no more symptoms.

Lung pain; splitting headache; could not sleep; feels run down; developed bubbles filled with fluid all over her lips; feels bad; achy; arm hurt; swelling and tingling sensation around my lip; swelling and tingling sensation around my lip; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 09Feb2021 at (at the age of 28-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified) for Meniere's disease. The patient previously received the first dose of BNT162B2 on 15Jan2021 and experienced achy, arm hurts, weird lung pain and splitting headache. Within minutes of receiving the second dose on 09Feb2021 the patient experienced swelling and tingling sensation around the lip and arm hurt. On 10Feb2021 the patient experienced bubbles filled with fluid over her lips in the morning, she felt bad and is achy; from an unknown date the patient experienced feels run down, weird lung pain, a splitting headache and she could not sleep. Therapeutic measures were taken as a result of the headache which included Aleve and she drank a bunch of water with her daily vitamins. The clinical outcome of the events lip swelling, tingling lips, lung pain, insomnia, fatigue was unknown; lip blister, feels bad, achy and arm hurt was not recovered; and headache was recovered The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Nausea, vomiting and bodyaches. Employee states her Left arm is swollen from injection site down to her hand. Arm is very painful to move.

Patient consent form shows no allergies to medications or vaccines and was given Pfizer covid shot. She was not on any medications, and no known allergies to food. After roughly 10 mins she said she felt tired, her head was feeling heavy, her heart rate increased. Patient stated she was able to breath fine, alert of surroundings. Alert x 4. Felt cold and shivering. Heart rate was 110, came down to 90, and then increased to 99. 02 level was 99. Temp 97.3. BP 134/72. Ambulance was called out of caution and patient transported to hospital.

Pt had chest pressure and slight pain starting 10 minutes after the injection. Patient then had worsening chest pressure and pain, slight nausea, dizziness, palpitations, and left upper extremity paresthesia which lasted a few minutes. The symptoms resolved but hen recurred later when she was in the post-vaccine monitoring area. Pt also felt pre-syncopal and was then sent to the emergency department. Her symptoms resolved shortly thereafter but she had an additional episode while waiting in the ED. She reports she currently feels some chest pressure and LUE burning. No exacerbating or alleviating factors. Not associated with shortness of breath.

I had chills, body aches; headaches; I felt feverish but I don' t know if I had a fever. Body aches were really intense - I didn't sleep the whole night. I had swelling a little on my arm - at injection site. My arm was sore. In general, my body was really sore and I couldn't get up from bed for 24 hours. I still had a bit of a headache and chills after the 24 hours so I stayed home from work 48 hours. I have been seen by a doctor -after the second vaccine, I had a flare up with my rash on my face (had been experiencing a rash on face prior to vaccine but this was a flare). My face flare up was that I broke out in a rash after finishing doxycycline. Didn't put me on another antibiotic because they wanted to wait and see with the rash - and the tests. Flare up - I couldn't eat; painful to wear a mask to work; couldn't sleep on my face. I was put on doxycycline again - on March 10th or 11th again because I couldn't handle the pain anymore. And it is getting refilled for another round. I have had to take a leave a absence from work the last two weeks.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out after receiving the Pfizer covid vaccine from a sitting chair position.

tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bilateral wheeze/ bronchospasm; Upper airway swelling; Tachypnoea: RR28; Sensation of throat closure; Irregular heart arrhythmia; Dry cough; This is a spontaneous report from a contactable other hcp (patient). A 28-years-old female patient receive dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, intramuscular left deltoid on 08Jan2021 07:35 at the age of 28 years as a single dose for covid-19 immunisation. Medical history included asthma from 04Apr2005 to an unknown date, obesity from an unknown date, seasonal allergy from 20Dec2007 to an unknown date , food allergy from 20Dec2007 (allergic to walnuts, peanuts, hazelnuts, palm oil) to an unknown date. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), docusate sodium (COLACE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), iron (IRON), calcium (CALCIUM) , diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), on 08Jan2021 07:05 and acetaminophen on 08Jan2021 07:05 for antipyretic prophylaxis. The patient previously took sunflower seed oil base and experienced hypersensitivity. The patient carries EPI pen but never used, received allergy shot for 6 years only uses drug allergy season. Historical vaccine dose 1 of BNT162B2 for covid-19 immunisation on 18Dec2020, Left deltoid, intramuscular, Batch/lot number: EJ1685 at 08:45 am at age 27 years. The patient experienced mild angioedema (local throat and tongue) considered medically significant on 08Jan2021 08:00 with outcome of recovered 14:30 , hoarse voice on 08Jan2021 with outcome of unknown , shortness of breath on 08Jan2021 09:05 with outcome of recovered , tachycardia HR 135 on 08Jan2021 09:07 with outcome of recovered , bilateral wheeze/ bronchospasm on 08Jan2021 with outcome of unknown , upper airway swelling on 08Jan2021 with outcome of unknown , tachypnoea: RR28 on 08Jan2021 with outcome of unknown , dry cough on 08Jan2021 with outcome of unknown , sensation of throat closure on 08Jan2021 with outcome of unknown , irregular heart arrhythmia on 08Jan2021 with outcome of unknown and "Vacematter 08:45". Lab data all reported on 08Jan2021 included heart rate: 135 and 130, oxygen saturation: 98 %, respiratory rate increased 28. Therapeutic measures were taken as a result of mild angioedema, hoarse voice, shortness of breath, tachycardia HR 135, bilateral wheeze/ bronchospasm, upper airway swelling, tachypnoea: RR28, dry cough, sensation of throat closure, and irregular heart arrhythmia. The patient took Benadryl 50mg at 09:10 and experienced irregular heart arrhythmia.

Sudden and continued nerve pain in the little finger and ring finger of the left arm at about 10:15pm

At 12:35 PM mother hollered for help, patient was pale, skin was cold and clammy, and slight left side facial droop, facial droop resolved pretty quickly, Patient was given soda to drink and a squad was called for further evaluation, squad arrived at 12:57, vital signs was taken, BP 106/72, Spo2 100%, Pulse 76, Patient refused to go to hospital, patient left with family.

At 4:15 pm, While under observation for 30 minutes, pt c/o heaviness in the eyes., and slight chest pain. pt. also c/o nausea and vomiting symptoms. pt. c/o numbness in the left arm. Pt. was encouraged to take deep breaths. Pt. was helped to the ground in a supine position. BP=140/90, HR=88, RR=18 . Pt was alert and oriented X4. 2 minutes after deep breaths, patient reported that all symptoms had subsided except numbness in the left arm.

Patient describes feeling dizzy and hot through top of the body. Patient had a low grade (99.8) temp and was advised by Physician to monitor temp for the next 4-6 hours. Consider a Covid test if temp goes over 100.4 degrees. Advised Patient to rest.

Severe migraine, and burning sensation on entire body. Especially in back/neck, ribs and vaginal area (even when I pee).

Slurred speech event for 15 seconds while working. Continued elevated DDimer and other various clothing labs post event. TIA event with continued hypercoagulation

fever, aches, chills about 7-8 hours after the shot. Lasted about 10 hours, and then a weakened level for another 12

Collapsed; difficulty breathing; weakness; Pain in chest; tingling all over body.; This is a spontaneous report from a contactable consumer (parent). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 10Mar2021 at 12:15 (Lot Number: EN6206) (at the age of 28-year-old) as single dose for COVID-19 immunisation. Medical history included bipolar from an unknown date and unknown if ongoing. Concomitant medications included lamotrigine (LAMICTAL); amphetamine aspartate/ amphetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate (ADDERALL) and alprazolam (XANAX); all taken for an unspecified indication, start and stop date were not reported. On 10Mar2021 at 12:15, the patient collapsed and experienced difficulty breathing, weakness, pain in chest and tingling all over body. The events resulted in physician office visit. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.

Generalized Tonic-Clonic Seizure; feeling unwell; slightly nauseous; still a little slow in speech and gait; still a little slow in speech and gait; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in arm right on 05Mar2021 08:00 as a single dose (at the age of 28-years-old) for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included epilepsy, hypopituitarism, central diabetes insipidus, neoplasm of brain, irregular menses, short-term memory loss, elevated LDL, and myopia w/ astigmatism. The patient had known allergies to surgical tape and contrast dyes. Concomitant medications included desmopressin acetate (DDAVP), lamotrigine (LAMICTAL), levetiracetam, and zonisamide; all were taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug allergy. On 08Mar2021 at 06:15 PM, the patient experienced generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait. Therapeutic measures were taken as a result of generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait as Nayzilam 5 mg two doses was administered. Clinical course details as reported: the patient finished dinner and evening medications before 6 pm and started feeling unwell and slightly nauseous soon after. Laid on sofa, started to sit up at 6:20 pm, and went into a Generalized Tonic-Clonic Seizure. The patient's father administered Nayzilam 5 mg (2 doses); seizure ended and the patient went into a deep sleep until 8:00 pm. The patient was largely recovered, but still a little slow in speech and gait. The outcome of the events was recovering as reported. Information on the lot/batch number has been requested.

feeling faint and hot; feeling faint and hot; the patient began to experience lightheadedness; Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable other health care professional. A 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206 and expiry date was not provided), via an unspecified route of administration on 12Mar2021, as SINGLE DOSE for COVID-19 immunisation. Medical history and concomitants were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The reporter stated that, during her 15-minute waiting period after the injection, the patient began to experience light-headedness and feeling faint and hot. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, facial swelling, lip swelling and tongue swelling. The patient received water, snacks and ice packs as the treatment. On an unknown date in Mar2021 the patient had differential diagnosis systemic reaction (hypoglycemia, hypotension, generalized rash). The reporter stated that that the patient having improvement of symptoms after observation in medical bay for 40 mins. She was to be taken home by her father who was able to come in to pick her up. The reporter stated that the patent wheeled to front by this provider and able to stand and walk assistance to car and she was monitored symptoms at home and follow up with PCP as needed. Outcome of the events was recovering. No follow-up attempts are possible. No further information available.; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

28 yo female received second dose of Pfizer COVID-19 vaccine 3/19 at 0933. Around 1130 pt reports numbness and tingling in her mouth and right sided facial drooping. Presents to ED. History of right frontal cavernous malformation, removed in 2013. PMH significant for migraine headaches and vestibular disorder. Evaluated by neurovascular with low suspicion for stroke. Symptoms improving. Received diphenhydramine, ketorolac and prochlorperazine in the CDU. CT brain and angio brain and neck without acute findings. Recommended pt to complete brain MRI with and without contrast to rule out possibility of stroke or underlying lesions to be performed outpatient. Pt discharged later that day with symptoms fully resolved.

Dizzyness, nausea, flushed, tingling in the legs. VR reported typical reaction to all vaccines minus leg tingling.

My left hand in the pinkie finger and ring finger are numb ,as well as my right hand is sore and hard to grip very painful, my throat glands are swollen, today I went to pass a bale movement and much strain so I removed it only to discover blood in it. I'm very worried about these health issues that have never been experienced,. March28,2021 Sunday morning bale pass blood seen and noticed around 9:30 am.

Patient reports sudden onset of severe nausea, sweating. C/o "not feeling well and feeling hot". Patient was assessed by onsite clinic EMS, vitals were taken and evaluated. Patient was monitored for 30 additional minutes. Patient's symptoms resolved, never vomitted. Patient disposition: went home and recovered feeling fine.

gradual facial pain; mild inflammation on the right side of face; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 19Feb2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa drug allergy, penicillin allergy, and evergreen allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included vitamin C and vitamin B complex, both from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that about 30 hours post-injection, she experienced gradual facial pain and mild inflammation on the right side of the face. The pain and inflammation lasted 6 hours and gradually decreased; she reported no droop or numbness. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of gradual facial pain and mild inflammation on the right side of the face were recovered in Feb2021. It was also reported that since vaccination the patient had been tested for COVID-19 on 23Feb2021 via polymerase chain reaction (PCR) nasal swab, and the results were pending (as of 24Feb2021).

Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling worse; Some feverish feelings; Hives all over my body, especially on my face; Chills; Couldn't stop shaking; This is a spontaneous report from a contactable consumer (patient, self-reported). A 28-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732 and expiry date was not provided), via an unspecified route of administration, in arm left, on 26Mar2021, at 14:00 as single dose for COVID-19 immunisation. Patient medical history was not reported. She did not have any known allergies. Concomitant medications included estradiol valerate, progesterone and cyanocobalamin (VITAMIN B12). Patient stated that she first experienced some feverish feelings, chills and hives 30 minutes following her vaccination. She drove home from the hospital and was feeling a bit off, but mostly okay. By the time she got back, she was feeling worse, around 4 PM. By 5 PM she had broken out in hives all over her body, especially on her face, swelling her eyes significantly and having her tongue go somewhat numb, starting to make it difficult to swallow. She also had significant chills, and couldn't stop shaking, and ended up being admitted to the ER. After being given antihistamines, the swelling went down and eventually the chills stopped after monitoring in the hospital. The patient was hospitalized for the events on an unknown date in Mar2021. Treatment received for the events. The patient was not diagnosed with COVID prior vaccination. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. Outcome of the events was recovered on an unknown date in Mar2021.

This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 AM (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Historical bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:15 PM (Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD). No covid prior vaccination, no known allergies and no covid tested post vaccination. The patient's concomitant medications included unspecified drug and not enough space. There is no other vaccine in four weeks. Patient experienced adverse events on 02Apr2021 included Arm Pain right after 02:00 AM, Headache around 2am, Nausea around 2:15am, Fainted around 2:20am, Weak Legs around 2:30am, Tingling in hand & feet around 2:30am, ringing in ear around 2:30am, Light fever around 7am, Headache persisting until just now after getting some sleep finally from 12pm-2pm now.AE resulted in Doctor or other healthcare professional office/clinic visit. There was unknown treatment were received for adverse events. The outcome of headache was not recovered. The outcome of other events was recovering.

This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

DVT in my right calf; I felt pain in my calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant; I felt pain in my calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 28-year-old female patient received second dose of BNT162B2 (Lot Number: ER8734), via an unspecified route of administration, administered in the left arm on 02Apr2021 as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: EP7534) for COVID-19 immunization. Medical history included corneal abrasion and pain in my calf, both from an unknown date and unknown if ongoing. Concomitant medications included tetryzoline hydrochloride (EYE DROPS [TETRYZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced DVT in her right calf on an unspecified date and 'felt pain in my calf between 10-20 hours before second vaccine dose. the pain went away but came back 5 hours after second vaccine dose. in the next 10 hours, the pain became severe and constant' on 02Apr2021. The clinical course was reported as follows: The patient felt pain in her calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant. At 40 hours after second vaccine dose, she went to the ER and was diagnosed with a DVT in her right calf. The adverse events result in Emergency room/department or urgent care. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of both events which included blood thinners. The outcome of the events was recovering.

Exposure during pregnancy; Sore arm; This is a spontaneous report from a contactable consumer or other HCP (Patient) via Pfizer-sponsored program reported for both mother and foetus. This is a mother case. The mother reported she was pregnant while taking BNT162B2 . A 28-year-old (pregnant) female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EJ1685) via an unspecified route of administration on 08Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EJ1685) via an unspecified route of administration on 27Jan2021 (at the age of 28-year-old) as single dose for COVID-19 immunisation. The patient medical history included induced labour, live birth-induced at 38.5 weeks for gestational hypertension- no other complications, Ehlers-Danlos syndrome (Father Side- sister has Ehlers-Danlos syndrome), mast cell activation syndrome (maternal aunt-Mast cell activation, none on mother side), alcohol use. Prenatal vitamins (once a day) from Oct2020. Concomitant medication included meclizine HCl (25 mg once/day) taken for nausea, motion sickness (car sick) from 27Dec2020 to 20Jan2021. The patient was 12 weeks pregnant (off label use, product use issue) on 08Jan2021. She was wondering if data was being collected, she knows that pregnant women cannot be studied for ethical reasons and was happy to be a part of any data sharing. The mother was 12 weeks pregnant at the onset of the event. In the first trimester of pregnancy, the patient was admitted to the hospital due to exposure during pregnancy and was fine later. Estimated due date was 08Feb2021 and for the first dose she was 10.5 weeks pregnant and for the second 13.5 weeks. She had no side effects except for a sore arm (pain in extremity) and so far no complications in her pregnancy. No other products were taken together. First day of last menstrual period was 25Oct2020, estimated date of conception was 10Nov2020 and estimated delivery date was 02Aug2021. The mother did not smoke, use illicit drugs nor drink alcohol during this pregnancy. Number of previous pregnancies were one and number of other children were one. History of sub-fertility included live birth-induced at 38.5 weeks for gestational hypertension, no other complications. No treatment for infertility, Negative results for serology tests and on 16Jan2021, first ultrasound showed all normal, left ovary-corpus luteum cyst. No problems before pregnancy. No drugs were taken by the father during the mothers pregnancy. The father did not smoke nor used illicit drugs but drank alcohol socially during the mother's pregnancy. Outcome was unknown for all the events. Information about lot/batch number has been requested. Follow up (12Feb2021): This is a follow-up spontaneous report from a contactable nurse. This 28-year-old female nurse reported in response to Non HCP letter sent which included lot number, adverse events, pregnancy due date. Follow up (16Feb2021): This is a follow-up spontaneous report from a contactable nurse. This nurse reported in response to Non-HCP EDP follow-up questionnaire sent which included pregnancy information and drug details.

Low grade fever; seizure; Passed out; syncope/ fainted; Blood pressure drop; Sore arm; This is a spontaneous report from a contactable consumer (patient's parent). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 28-years-old, via an unspecified route of administration in left arm on 07Apr2021 at single dose for COVID-19 immunization. Medical history included autism, being nervous, passed out, and anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT), quetiapine fumarate (SEROQUEL), gabapentin, bupropion hydrochloride (WELLBUTRIN), and lorazepam (ATIVAN) for being nervous. The patient received the Pfizer vaccine last Wednesday (07Apr2021) and immediately after that, at about 1:30 (unspecified), she just started having a seizure. They thought that it was more of a major response she was just having, fighting and was nervous about it, but it was kind of a different situation. The reporter has seen the patient passed out before. She did some blood test on 07Apr2021 and her sugars were fine. The reporter's concern was that they didn't know whether she should get the second one. The reporter didn't believe she got a seizure but was not sure about it. It's just that what immediately happened after she got the shot was that she passed out and they called the ambulance. After she passed out, she went to the emergency room and they did blood work on her. The reporter just did not know if they were going to let her go for the second dose because they couldn't relay if it was a seizure or a bizarre response where she just syncope and fainted. They were just thinking it was a bizarre response as it was just blood pressure drop but they were just not sure where to go from here. The patient was told to rest and intravenous fluid and something through the blood were given. The patient also experienced sore arm from 07Apr2021 for 2 days and had a low-grade fever the following day (08Apr2021). The outcome of the event sore arm was recovered on 09Apr2021 and recovered on Apr2021 for all other events. Information about the lot/batch number has been requested.

fainted; dizzy; warm; arms had seized up and were twitching; leg and body had also briefly been shaking; eyes were dilated; vomiting; arm is sore; sweaty; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:00 (Batch/Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination Medical history was reported as none. There were no concomitant medications. The patient previously had first dose of BNT162B2 (Lot number: ER8727) on 28Mar2021 01:00 PM in the left arm at 28 years old for COVID-19 immunisation and experienced fainted. On 18Apr2021 11:15 AM, the patient fainted about 10 minutes after second dose was vaccinated. The patient became dizzy and very warm and then woke up about 5-7 seconds after had fainted. The patient's arms had seized up and were twitching and leg and body had also briefly been shaking. The patient was very sweaty and warm. The patient's eyes were dilated when woke up according to the overseeing nurse. The patient said it was scary. Half hour after, the patient felt fine but then began vomiting when got home. The patient's arm is sore but nothing else has happened. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No treatment was given to the patient for the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was feeling dizzy and put the pt on the floor she was breathing and concious called 911 and the felt better and put her on a sitting position to rest. Her husband said she has dizzinees and fainting problem. we get help they came and assessed her and pt was ok and walked to her car accompanied by her husband. Called her around 5:40p to make sure she is doing ok but no answer

Migraine to the point of a blackout; Migraine to the point of a blackout; Shingles Breakout; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles breakout migraine to the point of a blackout on 18Apr2021. There was no treatment received for the events. The outcome of the events was not recovered. Information about lot/batch has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the report migraine to the point of a blackout and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Seeing black, spotty eyesight, almost passing out but was able to make it back to bed to lay down twice. Cannot stand or walk for longer than a couple of minutes unassisted (holding onto something) without breathing becoming shallow and dizziness setting in. Intermittent dizziness and inability to focus eyesight occurred throughout the day even if sitting down. Issues have been consistent throughout entire day. Not sure if this is adverse but also started having circulation issues in toes/fingers turning white & numb when either standing, walking or lying down. Experienced chills but only until ceiling fan was turned off. Circulation slightly improved except in feet.

headaches; severe kidney infection; drenching night sweats; Fever; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 as single dose for COVID-19 immunization in an hospital. Medical history included irritable bowel syndrome-constipation (IBS-C) from an unknown date. No known allergies. Unknown if with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. Concomitant medications included plecanatide (TRULANCE) for an unspecified indication and unspecified generic birth control both start and stop date were not reported. On 31Mar2021, the patient experienced fever and drenching night sweats. On 01Apr2021 the patient developed headaches. On an unspecified date on Apr2021, 4-5 days post vaccination of the first dose, the patient developed severe kidney infection treated with ciprofloxacin. The events required doctor or office/clinic and emergency room visit. The outcome of the events was recovered. The patient received the second dose on bnt162b2 (lot number: EW0164) on 19Apr2021 left arm for COVID-19 immunization.

On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air pressure,; Slight woozy/dizziness; Injection site soreness; tingly outside of left arm / left pinky; Very mild headache; tiredness; Stiff / sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; slight numbness/ Slight numbness in pinky fingers on both hands, and left toes; General "not feeling good"; nausea; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included developmental trauma disorder, drug allergy, allergies certain adhesives, borderline personality disorder, and irritable bowel syndrome. Patient is not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient experienced very mild headache, and mild tiredness were on 06Apr2021. On 07Apr2021 (day 2), patient was experienced injection site soreness, tingly outside of left arm/ left pinky. During day 6-7 (in Apr2021), patient experienced headache, stiff / sore neck (including upper shoulder area) left side of left arm and leg including hand and foot, tingly and slight numbness, general "not feeling good", slight nausea/ need to lie down, but not fatigue / wooziness. No fever. On 13Apr2021 (day 8), patient experienced slight woozy/dizziness, in waves. Slight numbness in pinky fingers on both hands, and left toes. On 14Apr2021 (day 9), on and off neuropathy in hands and feet, specifically left leg from knee down (outside of left toes and bottom of left foot) and pinky fingers, most notably when falling asleep/ waking up, or after being on my feet for a while. Right ear sensitivity/ "popping", like with changing air pressure, but on and off (most likely unrelated, but during same period). Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment for events. The patient underwent lab tests and procedures which included saliva test: negative on 13Apr2021. The outcomes of events were unknown.

Bell's palsy/droopiness on the left side of her face; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Apr2021 (at the age of 28-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Apr2021, she had drooping on the left side of her face. On the 25th, she went to the ER and it was Bell's Palsy. Her second dose will be on Thursday, 29Apr2021, and is wondering if she should get the second dose. On 27Apr2021, she reported the droopiness in her face is staying about the same. She had blood work done in the emergency department and her bloodwork was all normal. The patient underwent lab tests and procedures which included blood test: normal on 25Apr2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue

Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wednesday: 102-101 fever took only ibuprofen Thursday: called doctor fever 99-101. Tyenelol and antibiotics and immune boosters Friday: doctor oncall told me to continue meds and she will call me back on Saturday. Fever still 99-101 range.

Elevated heart rate within the first five minutes after injection. Went away in about one minute. Came back for about one minute in five minute intervals for a duration of about 40 minutes after injection. Feeling flushed with the first 15 minutes after injection. Soreness at injection site 24-48 hours after injection.

developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell; Tested positive; Tested positive; This is a spontaneous report from a contactable nurse reported for herself. A 29-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EH9899), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient was taking a multivitamin a day. The patient experienced typical symptoms no taste, smell on 22Dec2020, Slight tingling, body aches, chills, all the other symptoms for Covid and now positive for Covid in Dec2020. Outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for Covid based on the known safety profile.

Left hand feels sleepy; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 14:00 as a single dose, for COVID-19 vaccination. The patient had no known medical history or allergies. Concomitant medication included amoxicillin (AMOXICILLIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 16:45, the patient experienced left hand feels sleepy. No Treatment was given for the event. The clinical outcome of left hand feels sleepy was not recovered.

Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began 20 minutes after the injection. Lasted about 25 minutes. After this episode subsided, I continued to have persistent Dyspnea, chest pain, palpitations and heart racing. Was unable to speak in full sentences, exercise. Walking short distances caused extreme SOB. These symptoms lasted about a week.

Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypnea without SOB; Sudden elevation of BP 178/100; Dizziness; Nausea; skin tingling; This is a spontaneous report from a contactable other healthcare professional, who is also the patient. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), via an unspecified route of administration in the left arm on 30Dec2020 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. Medical history included Psoriasis, psoriatic arthritis, exercise induced asthma (no inhalers or treatment for >10 years). The patient had known allergies to methotrexate and chlorhexidine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included apremilast (OTEZLA) 30mg BID (twice a day), bupropion hydrochloride (WELLBUTRIN XL) 300 QD (once a day), and buspirone hydrochloride (BUSPAR) 5mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 30Dec2020 at 12:30 the patient experienced sudden onset of tachycardia and palpitations and tachypnea without SOB within 3-5 minutes of injection. The patient also had sudden elevation of BP 178/100, dizziness, nausea, and skin tingling. The patient's BP gradually came down over 60 minutes. The dizziness lasted about 50- 60 minutes. No medication or medical assistance required. The patient was able to drive home. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 27Dec2020, with Test: Nasal Swab and Result: Negative.

Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.

feeling flushed; facial swelling; This is a spontaneous report from a contactable physician reported for self. This 29-year-old female (No pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 23Dec2020 14:30 at single dose for COVID-19 immunization. No COVID prior vaccination, No COVID tested post vaccination. No known allergies or other medical history. No other vaccine in four weeks, No other medications in two weeks. The patient got the vaccine Wednesday afternoon (on 23Dec2020 14:30), then Thursday evening (>24h, 24Dec2020 07:45 PM) started feeling flushed and had facial swelling after dinner. No other symptoms. Resolved with Benadryl. Then again Saturday morning while brushing teeth and Saturday evening after dinner. One more time Sunday morning during breakfast. Each time the symptoms were milder than before. Took Benadryl as needed. No new foods, meds etc. The outcome of event was recovered.

1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain hot sweat chills and diarrhea

Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 29DEC2020 09:15 as a single dose for COVID-19 immunization. Medical history included depression from an unknown date and unknown if ongoing, and Covid-19 on '17th of this month ' and unknown if ongoing. The patient had no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), spironolactone (SPIRONOLACTONE), desogestrel, ethinylestradiol (KARIVA). No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. On 29Dec2020 16:30, the patient experienced Arm pain that gradually turned into body pain, joint pain, chills. The pain was so extreme. Patient had Covid on the 17th of this month and was not told that you should wait 90 days after to get the vaccine. The patient reported her response was worse than the side effects of Covid. The events result in a Physician Office Visit The patient was treated for Arm pain that gradually turned into body pain, joint pain, chills with Heating pads, Ibuprofen (Manufacturer Unknown) and Tylenol alternated. The clinical outcome of arm pain that gradually turned into body pain, joint pain, chills was recovered. Information regarding lot number has been requested.

Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.

Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. Has persisted since.

5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore throat

Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely sore arm with injection site.

Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative: 12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.

Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Next morning, I woke up with severe positional headache (headache with standing or sitting up, resolved completely with ibuprofen and tylenol within 20 minutes). The next morning I also had a sore left deltoid, and soreness extending into my left chest and shoulder, which diminished throughout the day after ibuprofen and tylenol. I also had a left swollen armpit, which I interpreted as swollen lymph nodes. My left armpit was sore and was visibly swollen compared to the right. The left lymph node is still visibly swollen as I report this (approximatley 36 hours after vaccine administration), and is sore but less sore than initially. Of note, when I received the first vaccine in this series, my left deltoid was more sore than with the second administration, but soreness was limited to the deltoid and resolved within 3 days.

Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feeling faint and a bit of heaviness. Assisted patient to the floor with head supported with jacket in supine position with feet elevated. Patient did not faint. Obtained vitals 1914 BP: 103/68, HR: 67., o2: 97%. Patient denies being pregnant, but states that she has started a diet. Pt states eating yogurt prior to receiving the vaccine. Continued to monitor patient, no change in status. 1920 BP 129/75, HR: 80, o2: 98%. Patient states feeling better, asked to sit up, still on the floor. 1930 BP: 119/77, HR: 71, o2: 98%. Offered patient apple juice, pt able to tolerate PO liquids. 1940 patient assisted to sit up in chair BP: 134/89, HR: 72, o2: 100%. Patient continued to remain stable with improvement, no feeling of faint or heaviness. 1950 patient transitioned to standing position BP: 118, HR: 75 , o2: 95%. Pt walked around clinic to see if she could tolerate walking. Pt states having to drive home, asked if a ride was available, pt stated no. Pt states feeling fine to drive home. Pt discharge @ 2000 in stable condition.

25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 minutes later entire tongue tingling/prickling. Another 5 minutes lips began tingling/prickling. Epi-pen administered by military staff present for vaccination. Taken to ER and received a dose of Benadryl and prednisone.

29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and nausea after receiving the second Pfizer COVID-19 vaccine around 10 AM. Patient says that after her first dose of the vaccine she had mild sore throat and hoarse voice that resolved spontaneously. She had her vaccine around 10, several hours later before coming to the emergency department between 2--230 she had the sudden onset of difficulty speaking with associated sore throat and nausea. She has had dry heaving but no large amounts of vomiting. She has not had stridor, wheezing, shortness of breath, syncope, or the development of a rash or hives. She has not had a reaction to her prior vaccines she does not have any other allergies in general. She has otherwise been well recently without infectious symptoms including fevers, chills, cough, and has not been exposed to Covid to her knowledge. Medications administered in ED included diphenhydramine 50 mg IV once, dexamethasone 10 mg IV once, famotidine 40 mg IV once, ondansetron 4 mg IV once. Had brief episode of shaking and R arm rigidity in the ED. Patient denies LOC during the episode, did not have a post ictal state, no tongue biting or episodes of incontinence. Given single event without LOC, less concern about episode being a seizure. Patient has had no further episodes of shaking since admission. CT brain was wnl, no FNDs noted on exam.

Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards of glass. By day 3, swelling in left arm and lymph nodes under arm, armpit, and side of breast. Tingling in left arm down to fingertips and "dead arm" feeling.

Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, clamminess, shaky, dizziness

strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extremely sore arm; This is a spontaneous report from a contactable nurse, who is also the patient. This 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 at 09:00 at single dose for COVID-19 immunisation. Vaccination facility type: workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included asthma, hypothyroidism, seasonal allergy, allergy to pine nuts and almonds and past drug history included allergy to levofloxacin (LEVAQUIN). Concomitant medications included ethinylestradiol/norethisterone acetate (LOESTRIN), levothyroxine sodium (SYNTHROID), fluticasone furoate (VERAMYST), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). On 17Dec2020, within a few minutes of receiving the vaccine, the patient noticed a strange feeling in her throat. The patient stated that it was difficult to describe, but only lasted a minute or so. That night (17Dec2020), as she was getting ready for bed, she felt like a fever was coming on, but she checked her temperature and it was 97.6 (her normal temperature). She woke up around midnight shaking, with a temperature of 102. She took ibuprofen and it came down to 100.8 before she fell back asleep. In the morning, her temperature was down to 98.5 and she did not experience any additional fevers. The only other symptoms she experienced were fatigue and an extremely sore arm. These lasted about two days. The patient recovered from the events strange feeling in her throat on 17Dec2020 and she recovered from the fever on 18Dec2020; the patient recovered from the other events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was tested for COVID-19 with a nasal swab on 31Dec2020 which was negative.

Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only lasted a few hours. Intense body aches, chills, low grade temp, started at 00:30 and ended by 1800. Still experiencing intermittent chills, flushing, and sweating.

Low grade fever, fatigue, chills, sore arm. Narrative: Low grade fever, sore arm, chills, and fatigue developed after administration of covid vaccine. Resolved by 1/1/21.

Exquisitely tender right sided epitrochlear, axillary, and supraclavicular lymphadenopathy. Began about 16 -20 hours after receiving vaccination. Still present at 36 post vaccination, but seems to be improving.

Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction. Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot

Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body aches for 24+ hours, abdominal pain for 2 hours.

Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.

1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my chest and neck that lasted for about an hour. No itching or hives. 1/9/21 at 3am my heart rate started to increase to about 110bpm while sleeping and continued till 4am. 1/9/21 at 4am my apple watch alerted me to my heart rate was above 120bpm while resting. This is when I realized I was sweating and felt like I had a fever. I drank water and went back to sleep. 1/9/21 5am heart rate was at 135. then 6am 148bpm. 7am around 161bpm. Kept trying to go back to sleep. 1/9/21 8am got up and took an adult benadryl tablet and drank plenty of water. Tried to relax to lower my heart rate. 1/9/21 9am took another adult benadryl tablet and was able to get my heart rate just below 120 while sitting. Then ate breakfast and went back to bed. If heart rate was not going to lower, I was planning on going to the ER. 1/9/21 10am till next day. Heart rate was then under 100bpm. I was then so tired that I slept all day and did not eat anything else. 1/10 I experienced severe body aches, chills and headache. This was all day. 1/11 I woke up feeling mildly nauseous for about 3 hours and then dizzy for about an hour. after that I just had a sore arm. 1/12 Had a mildly sore arm.

During the first few hours following vaccination, I had soreness at the injection sight and a mild headache. About 10hours later, I started to experience more severe symptoms including a fever of 101-102deg, chills/cold sweats, a moderate headache, and body aches. This continued throughout the night and into the next day. In addition, I began to experience a burning sensation in my chest, similar to heart burn. I have consistently been taking Tylenol and recently took Tums to aide with the heartburn feeling.

Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began to start breathing rapidly and become short of breath. Also, red blotches started to develop around her neck. Epi 0.3 mg IM given along with diphenhydramine 50 mg orally.

Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day. Went to sleep with no issues. Woke up at 2:00am uncontrollably shaking with chills/goosebumps, sweating with shortness of breath. Extreme headache and all over body soreness also at that time. This continued in waves for the next several hours. I finally slept for a short time and woke with continued headache and muscle/joint soreness. This was accompanied by dizziness, nausea and decreased appetite. This persisted throughout the entire next day following vaccination. The day after that was slightly better and the subsequent day I felt relatively back to normal. I checked for fever many times throughout the symptoms but was always afebrile.

body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events. No follow up attempts are possible. No further information is expected.

she is having a hard time sleeping; swelling; She developed a knot on the side of her neck that was very painful; She does not know if it is a swollen lymph node; right arm pain; pain started traveling up her neck to the shoulder area.; pain started traveling up her neck to the shoulder area; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 24Dec2020 08:30 at the first single dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient received vaccine in Right arm. She got the Pfizer Covid19 vaccine on 24Dec2020. The right arm pain started two hours after getting the vaccine and the arm pain got progressively worse and the pain started traveling up her neck to the shoulder area on 24Dec2020. The patient experiencing Right neck pain and swelling on 26Dec2020. She developed a knot on the side of her neck that was very painful, along with arm pain that went up to her neck on 26Dec2020. The knot developed about 2 days after she got the vaccine and now the knot is getting larger. She does not know if it is a swollen lymph node but she has never had a swollen lymph node in that area, states it is above her collar bone and the knot is very painful. She is thinking to go to urgent care since it is bothering her to where she is having a hard time sleeping. On 26Dec2020 she noticed it was painful in the particular spot where she found the knot. Her arm pain went away by the 27Dec2020 and it was not too painful any more, she clarifies her arm pain recovered completely as of 27Dec2020. The painful knot has gotten worse. The patient did not receive any treatment for the events. The outcome of event right arm pain was recovered on 27Dec2020; outcome of event knot on the side of her neck was not recovered; outcome of other events was unknown.

Employee was vaccinated on 1/12 prior to start of shift. Called this am to report feeling extreme fatigue and arm soreness. Stated she was not able to tie her hair or use arm without pain. Denies fever, body aches at this time.

Fever 101.0F; chills; headache; fatigue; arm soreness; second dose on 05Jan2021 15:30 /first dose on 18Dec2020; This is a spontaneous report from an other hcp. A 29-year-old female non-pregnant patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284), via an unspecified route of administration at left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. No known allergies. No other medical history. Concomitant medication included ibuprofen, alprazolam, ergocalciferol (VIT D), clarithromycin (CLARITIN), cranberry. No other vaccine in four weeks. The patient received first dose (lot number= EK5730) via an unspecified route of administration at Left arm on 18Dec2020 at single dose for COVID-19 immunization. The patient experienced Fever 101.0F, chills, headache, fatigue, arm soreness on 05Jan2021 20:00. The patient underwent lab tests and procedures which included body temperature: 101.0 fahrenheit on 05Jan2021. No covid prior vaccination, Covid was test post vaccination via Nasal Swab on 22Dec2020 with result of negative. The events Fever 101.0F, chills, headache, fatigue, arm soreness were recovering. Treatment of acetaminophen received for the events Fever 101.0F, chills, headache, fatigue, arm soreness.

Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours. Arm soreness was quite severe on 1/8, as it was painful to even lift the left arm for much of the day. I also noted, about 5 hours after vaccination, that my jaw felt slightly tense, bilaterally. On Friday, 1/8, I also experienced headache for the entire day, and I was fatigued for much of the day. I noted clavicular lymph nodes as well. About 18-20 hours after vaccination, I developed soreness in my back, and about 24 hours after vaccination, I noted some myalgia in the left leg. These symptoms were responsive to acetaminophen. The headache, clavicular lymph nodes, arm soreness, and myalgias were resolved by the time I woke up on 1/9. Finally, I noted development of an axillary lymph node during the evening of 1/8, about 28 hours after vaccination. This axillary node persisted until Monday, 1/11.

Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness

1 week history of significantly worsened (previously present "low back strain" lower back pain that had become radicular to both LE and associated with progressively worsening bilateral LE weakness, paresthesias since COVID vaccination last week. see continuation for HPI and assessment/plan from office note 1/13/21 HPI from OV dated 1/13/21 She had presented initially in December 2020 for her annual physical, and we evaluated some low back pain that that time, felt to be a sprain/strain resulting from a fall in the shower earlier December which was aggravated significantly by lifting/transferring a patient at the SNF she works for as a nurse. Presentation at that time was rather benign, no imaging obtained, pt was placed on leave from work for 1 week to avoid the heavy lifting and likely aggravation of back pain, and rx including diclofenac and cyclobenzaprine. She did not FU in the office, but returned to work at SNF a week after I saw her for the back pain. She states she had improved enough to feel like she could go back to work but wasn't 100% without back pain yet. At no time was comp mentioned at the visit in December. She did tell her employer about the injury and was off of work for a week and was encouraged to seek comp. We were never notified. Yesterday 1/12 she followed up in the office for the back pain and was found to have much more severe pain, now radicular to both LE (pain intensity worse on right), with new neurologic impairment including objective weakness bilateral LE (R>L), sensation disturbance bilateral LE (R>L). Xray of lumbar spine obtained in clinic, this was essentially unremarkable, non-acute. Pt was sent for stat MRI of the lumbar spine. MRI last night revealed no findings to explain her severe symptoms - she has mild symmetric disc bulging at L5-S1 nd mild bilateral facet arthropathy with patent canal and foramina, and a mild nonspecific "STIR signal abnormality" within the soft tissues abutting the left lateral aspect of the L5 spinous processes felt to be small and nonspecific. I did discuss the case and the imaging with the radiologist and he feels this is unlikely to be the source of her back pain/radicular symptoms. No obvious signs of apparent discitis or any signficant soft tissue abnormality. Pt contacted last night with initial "normal" results of MRI as formal results were pending - hydrocodone was sent to her pharmacy for pain relief overnight. Pt received 60mg toradol in the office yesterday during her visit. Pt noted significant improvement in her back pain, bilateral leg pain about 30 minuts after that injection. She continued to have pain in the evening but went to sleep. She woke at 3am unable to roll over due to weakness and pain - her sister gave her a hydrocodone and she went back to sleep' she woke this morning feeling much better; today, she has less severe low back pain, less severe right lower leg radicular pain, NO pain radiating into the left LE, lessening of the weakness in her right LE, lessening of paresthesia reported in the right LE (now isolated just to the heel), resolution of the weakness in the left LE, resolution of the tingling of the left knee. Other than the toradol and one dose of hydrocodone, no other medications were given, no other treatments given since presentation yesterday. Upon further questioning, patient does reveal that she received the 1st of 2 COVID-19 vaccinations (pfizer) last week. She received the vaccination at work at nursing home on 1/7/21. She had some relatively quick onset nausea and dizziness within an hour of the injection, but that resolved. She recalls feeling like her low back pain, bilateral lower leg pain, leg weakness and paresthesias all intensified sometime either Wednesday 1/6/21 or 1/7/21, but more obviously worsened over the weekend 1/9 and 1/10. Along with the lower extremity symptoms, she does admit today that she experienced soreness in bilateral upper arms starting the day following the vaccine administration, with left arm/shoulder still feeling sore and tender to the touch now. She also developed some altered sensation of the right thumb and index fingers the day following vaccination (1/8/21) and this has been persistent/unchanged. She is right handed. No prior issues with right hand/fingers. Other than the altered sensation, she denies pain, swelling, or notable weakness. She is right handed, and really hasn't done much with her right hand over the past week since she hasn't been working. Patient denies having significant headache, fever, chills, diaphoresis, fatigue, rashes/injection site erythema since the covid vaccination. She was not told to sign up for or told about the V-safe program and hadn't thought to report her symptoms to work or think to be concerned regarding possible vaccine SE. Pt denies prior hx of low back pain, neurologic symptoms including weakness/paresthesias, previous allergy to or adverse reaction to vaccination or injectable medications. She has a history of latent TB(fully treated) but is otherwise in good health. After gathering much further detailed information/history today from patient, review of chart including the MRI results and xray results from yesterday, my prior OV note, and discussion with radiologist today regarding her MRI - I Discussed with patient and her sister that I believe what is becoming more apparent to me now is that she is likely suffering from an adverse event associated with the COVID-19 vaccination she received on 1/7/21 through her workplace. I'm unable to define this for certain, but I suspect that she developed the progressive worsening of low back pain, development of radicular pain and bilateral LE weakness and paresthesias about 1-2 days following the vaccination administration. She has had notable and rather surprising improvement in both subjective and objective findings Today as compared to yesterday. Only intervention was toradol 60mg IM and one dose of hydrocodone, she had already been taking diclofenac or ibuprofen so I believe the only explanation for the improvement over the past 24 hours is the fact that she is gradually having resolution of the temporary paraparesis, neuralgia, paresthesia brought on by the recent COVID-19 vaccination. I believe she truly had injury to the low back in December, initial injury at home but had improvmenet and then significant worsening/exacerbation when transferring a resident at work. Her presentation following that was consistent with a strain/sprain of the lumbar spine. This was treated appropriately with rest, activity modification, stretching, NSAID, and muscle relaxers. She returned to work w/o restriction likely earlier than she should have but I believe the covid vaccination is likely what caused her condition to so significantly decline; Its also possible that her physically demanding job requiring lifting/transferring/standing for prolonged periods of time on top of an only partially resolved low back strain had aggravated her low back condition. plan from OV dated 1/13/21 Given the improvement since yesterday, I recommended obtaining some labs looking for any sign of alternative explanation including infectious etiology or autoimmune/inflammatory condition, however will hold on further imaging as would be the plan, specifically EMG of the bilateral LEs. Explained to patient that I'm hopeful with continued rest and time, her symptoms (weakness, tingling/numbness, radicular back pain) will completely resolve. She may need some eventual PT for the disc bulge in the lumbar spine and lumbar strain that is likely still lingering. Will contact pt with any change in care plan based on the laboratory findings. I would like to closely follow her, and make sure her symptoms continue to slowly improve /resolve. If at any point she develops worsening symptoms again or any new neurologic signs/symptoms (and we discussed what emergency signs/symptoms would be) then she needs to be in touch with me right away. I will work on reporting this suspected adverse covid vaccine reaction to VAERS / possibly also CDC and see if they have any additional input/suggestions for monitoring/treatment. For pain control, pt may continue with the diclofenac OR ibuprofen, and the hydrococone/APAP as needed for breakthrough severe pain uncontrolled with the NSAID. I have advised pt to remain off of work at this time, resting at home avoiding lots of physical activity as she continues to heal. Suspect will have her follow up in clinic sometime next week for repeat evaluation/examination depending on VAERS/CDC recommendations and of course the lab results and any updated condition reports from the patient in the interim. Will want to make sure she has full resolution of the paresis and adequate resolution of her back pain/radicular pain prior to returning to work, even in a limited capacity. I am informed today that there is light duty available and will keep that in mind. Pt to be contacted regarding follow up. Encouraged to call with questions/concerns/updates. Pt was very thankful for the care.

1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken: bp-155/97, P-77, O2@98%, R-16. Reported to pharmacist who adm. vaccine, staff member was given water and told to stick around an additional 15 min for monitoring. 1257: Pharmacist rechecks staff member and notices Blotchy redness to her neck and chest, does not report signs of itchiness but does feel warm, window opened nearby, cont. to monitor staff member, 1320: staff member reports she feels better. 1309: staff member rechecked by pharmacist,

Chills, Fatigue, left arm pain and fever of 100.3. Treatment include Tylenol with no improvement at this time.

I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I started feeling a little tired and some pain around the injection site. I had anticipated this as I felt similar symptoms from the first dose of the vaccine. I took a nap and woke up around 09:00pm feeling some of the worst body aches I had felt in a long time. My arm that I received my vaccine in was painful and warm to the touch. I felt dehydrated as well so I drank a pedialyte, took OTC Tylenol extra strength, and laid down again. Around 07:00am on 1/13/21, I still felt achy, sweaty, and felt pain in the arm that I recieved the vaccine in. I went into my bathroom, and noticed two small red and raised areas around the injection site. I took pictures of the site, and continued to closely monitor through out the day. I ended up calling in sick to work on 1/13/21. It is now around 12:00pm on 1/14/21, and I woke up with a pounding headache, muscle aches, dehydration, nausea, and low energy. I feel like I am hungover or have the flu, and am planning on calling in sick to work again. I reported my symptoms to my staffing department at my workplace on 1/13/21 and wanted to file a report here as well.

Lymph node swelling to right axillary with pain that radiates to the right breast, down the right arm, and around the back to the right shoulder blade. Pain limited daily activity to the right arm. Pain decreased for about 12 hours and then the pain returned again around 06:00, Thursday 1/14/2021 with lymph node larger than previous day. Area is tender and painful with every day movements. Will consult with primary health care provider if pain/swelling does not improve or gets worse.

Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, and fatigue for about 30 hours. Post 3 days after injection all finger tips have been cold, red, numbness, and tingling. Now post 5 days after injection finger tips have improved but still red, cold and difficult to get warm.

Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, severe fatigue, sweating.

Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on nose (itchy and burning). Jan14- extreme fatigue, nausea, loss of appetite, rash continues but no itching, light on burning, body aches, cold, could not get warm, temp stayed around 96.0-97.0 Jan 15- fatigue, nausea, extreme congestion, sweats, symptoms of a fever over night and during day. Cold sweats, shakes, cold then hot, body aches, fatigue. These happened off and on through the day. When started feeling crappy took temp and it was 99.6-99.8. When feeling cold temper drops down to 97.0 scratchy voice voice congestion, runny nose, little sore throat, when swallowing pills or hard texture foods, sometimes drinking something. Overall feeling of a cold. I think it?s important to note that I had Covid-19 in the month of November and received my first vaccine December 22nd. I had side effects after the first shot but not nearly as bad as this time. I am nurse in a doctors office if that matters at all. I am still feeling under the weather but wanted to get these down before I forgot them.

Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Start Date/Time: 08Jan2021 12:45 PM/ Start Date/Time: 21Dec2020 10:15 AM; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date not reported), intramuscular in the right arm on 08Jan2021 12:45 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the right arm on 21Dec2020 10:15 at single dose for COVID-19 immunisation. The patient experienced significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose. No treatment was received for the adverse events. Clinical outcome of the events was recovering.

whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.

Received vaccine around 8 am, arm soreness within 4 hours of administration. At midnight (16 hours after administration), woke up with chills, body aches, headache, hands and feet hot, skin hot to touch/tactile fever.

Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, I began experiencing nausea, vomiting, moderate body aches, and headaches. I have been unable to keep down liquids (including water, gatorade, and soup broth) and solids. At this time, I have continuous vomiting, with each following the intake of food and/or beverages. Physical exam is negative for redness, swelling or rash at the injection site. Additionally, I have not appreciated any fever or signs of anaphylaxis. Following my first dose in the two-dose series, I did not experience any side effects other than the expected sore arm for 24-48 hours.

10 hours since second vaccination I had muscle aches, chills, myalgia, nausea, headache, and fatigue. This went on for.36-48 hrs. After flu like symptoms subsided,I started to get pins and needles in both feet, legs, and hands. Then twitching and muscle spasms in my legs.

Twelve hours after receiving vaccine patient began experiencing chills & body aches. The next morning (24 hours post-vaccine) the patient had a very bad migraine, chills, and body aches. Upon standing felt nauseous & dizzy, then saw black dots and vision went black for several minutes and fell to floor. Relative called 911 and vision had returned by the time medics arrived. Vitals were normal, except for low blood pressure. She took Advil and felt better by the evening.

About 12 hours after the vaccine, I started having arm pain at the site and low back pain which is very unusual for me as well as a dull headache which is not uncommon for me. Around midnight I woke up with chills, and severe arthralgias in all joints down to the toes and fingers, and deep, boring pain in my long bones and neck. My skin and fingertips felt like they were burning. I was nauseated but didn?t vomit. I was up all night because I couldn?t find a position I wasn?t in pain in. Tmax 100.3 F. Took a gram of Tylenol with improvement of symptoms. Felt better in AM but when Tylenol wore off around 9 am, had another wave of the same pain all over. Tylenol improved. Felt almost completely normal by 4 pm with the exception of some lingering low back pain (central not muscular).

Approximately 12/13 hours post-vaccine dose #2 I was woken from my sleep with severe body aches. Extremely uncomfortable, from neck to back to calves, without improvement with Tylenol or ibuprofen, causing me to be unable to sleep. Around hour 20 post-vaccine, I started to get chills. It wasn?t just feeling cold or shivering, it was full body convulsions that lasted approximately 15 minutes. I became nauseas and dizzy after that for about an hour, unable to stand or walk anywhere. The severe body aches continued, with no improvement from Tylenol or ibuprofen or heating pad. Aches resolved around hour 30 post-vaccine and the only symptom left was pain at the injection site.

Immediately after the vaccine administration, she felt tingling around her lips, swelling of the lips, slight facial and chest flushing. She was given Benadryl 25 mg PO and sent to the ED for further evaluation. In the ED she was given famotidine 20 mg IV push once, methylprednisolone 125 mg IV push once, and a bolus of NaCl 0.9% 1000 mL over 65 minutes. Patient was asymptomatic 3 hours after vaccination.

Second dose of COVID vaccine (Pfzier/BioNTech) received Friday morning around 8:00, I left work about an hour early that day due to rising nausea, migraine and fatigue. By the time I got to my car in the parking garage I had thrown up and was so dizzy that I called my boyfriend to come pick me up. When I got home I immediately laid down to take a nap. 3 hours later I woke up very sore and achy and still had a migraine. I remained in bed and later that night I spiked a fever as high as 101.8 fahrenheit. I had severe chills and the aches were so bad that my bones hurt all over and it felt like someone was stabbing me with a metal broom handle. Pain spiked to 8 on the pain scale and with the length of time I had this pain, it was one of the worst experiences of my life. The dizziness and fatigue caused me to need help to get out of bed to use the restroom. I took ibuprofen frequently and Nyquil at night to help relieve the effects without it doing little more than taking the edge off. Saturday night was the same as Friday night with no relief of symptoms. Fever remained around 100.9. Sunday night it dropped to 99.8 with chills, dizziness and fatigue still remaining but aches slightly lessening. Monday night I was still dizzy and weak but not nearly as in much pain and fever had subsided. Tuesday I started to feel more normal by the end of the night, just easily out of breath and off and on again headache.

Symptoms within 15 minutes of vaccination. Staggering, flushed and dizzy. Low pulse. Passed out while sitting in the chair while waiting to go to ED. Regained conscious within 1 minute, disorientated, complaining of chest pain. Taken to ED - thought to be a vasovagal episode.

I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking with management and felt faint and short of breath, continued to be tingly. Last night 1/19/21 I had a moment of not feeling well and my heart rate went from 60s to 120s with shortness of breath and nausea qnd tingling. This continued for about 30 minutes, I was debating going to the ED for the SOB. I then became really cold and had such bad shaking I couldn't hold anything for another 20 minutes. Today I continue to have some tingling. All of this on top of the expected side effects.

I had tingling in the right side , opposite arm of the injection. I felt it from the forarm to my hand and the top of my foot.

Main reaction: very achy wisdom teeth area (pulled ~10 years ago), all other teeth fine, for ~ 10 days Also: headache and dizziness night of vaccine, sore arm ~2 days

Sore arm; swollen/tender lymph nodes in armpit of injection arm; swollen/tender lymph nodes in armpit of injection arm; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249 and expiry date: unknown), intramuscular left arm on 10Jan2021 09:45 at single dose for COVID-19 immunisation. The patient medical history was not reported. Patient was not pregnant. Concomitant medication included melatonin, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient took the 1st dose (lot number: EL4284) on intramuscular left arm on 23Dec2020 10:15. The patient experienced sore arm, swollen/tender lymph nodes in armpit of injection arm, headache, chills, fatigue on 10Jan2021 19:30. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.

Began about 1.5-2 hrs after vaccine Hives, red rash all over face and body. Fever of 103 disoriented trouble breathing and speaking and remembering. Dizzy. Alternating high and low blood pressure. Chills. Body aches. Sore tenderness and warmth at injection site. Sluggish speach

First Dose- I had a headache after the shot and tremors started that even and throughout the night. No fevor. Arm very sore, going into neck. Second Dose- Felt find the night. Woke up that morning at 1am and with tremors and in a night sweat. Checked temp and it was only 96, but felt hot and was sweating. Woke up the next morning and my entire body, muscles and joints ached. My knuckles, ached, kept getting sharp pains in my knuckles. My jaw ached, difficulty eating. My entire body, my muscle ached, difficulty moving. I didn't get a headache till that evening. I also had severe heart burn that night, not sure if it was related, but I have never had heart burn that bad. The next morning when I woke up (5am) (now two days after my shot), again my joints hurts, I couldn't even stand. Its like my knees couldn't even support me and I had a massive headache. I went back to bed and woke around 9am, no longer had a headache, muscles still hurt. Around 11am, all of a sudden, muscles and joints felt fine. The only thing (day three) is my arm pit on my left side where i got the shot is bothering my extremely bad. I was able to put an ultrasound probe on my axilla area, and I have swollen lymph nodes in my axilla in the area that is very painful. I also have a dull pain in my elbow.

Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wierd, light headache

Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused further care and her symptoms improved then left the waiting area at 2:55pm. Before leaving, her vitals were BP 133/69, HR 70 and SpO2 100% on room air.

Severe nausea, vomiting, blood pressure changes, heart rate changes, dizziness, slurred speech. Sent to ER for monitoring and fluids.

Numbness and tingling in right arm. It started the night of 1/21/21 and is still happening. Intermittently it feels like my arm and fingers are falling asleep.

-dilated eyes around 8 pm day of injection -extreme soreness in left arm day of injection -extreme body aches, chills, and sweats day of injection -insomnia that lasted from day of injection to early morning the next day. This was not anxiety related. -Frequent burping the night/overnight after getting injection -feeling of being hungover the day after the injection but this could be due to sleep deprivation from the insomnia.

I started to experience back pain and light spasms two to three hours after the second vaccine shot. When I woke up the next day I was unable to move. I have had intense back spasms which make it hard to; walk, pick up items, and walk up/down stairs. I have been bed ridden since I received the shot getting up to eat and do light stretching.

About 24 hours after 2nd dose of vaccine received 1/23/21, really intense migraine started. Started about 4pm, lasted through going to sleep at 9pm, and then woke up fine.

Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021. Information about lot/batch number has been requested.

Day of vaccine a few hours later I had a migrane start to form and I felt off. Sunday morning the migrane had ebbed a bit until about 12 noon. By that point I was in bed almost all day with muscle pain in my torso (back, ribs, abdominal). I also had a severe migrane and a fever that at it's worst was 102.3. It was brought down quickly with ice to 100.7 within an hour. After about 8 hours it subsided for about 20 minutes before the torso pain and migrane came back. The fever stayed around 100.3 when I last checked. I went back to sleep for the rest of the night and felt fine in the morning with no fever.

Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/14/21. Initial symptoms of mild/dull dental pain started on 1/19/20. on 1/21/21 and 1/22/21 started getting EXTREME right-sided oral/facial nerve pain/spasms that migrated to head that occurred intermittently every 30-60 min and lasted 2-5 min at a time in the evening. Saw dentist on 1/22/21 to check for issues with teeth, no dental issues were found on exam and on xray. Symptoms similar to trigeminal neuralgia/ bells palsy. Called Teledoc on 1/22 who suspected bell's palsy and prescribed prednisone 50 mg po qday x 5. Nerve pain attacks went always after first dose of prednisone. Currently still left with mild dull right-sided pain.

I received the COVID Vaccine yesterday (1/24/21) around 12:10pm. I experienced no effects while waiting the allotted 30 minutes. The next morning, January 25th 2021, I started to experience arm soreness and blurry vision. The blurry vision is worse in my left eye. My vision has not improved after waking up, taking a shower and putting saline drops in both eyes. The best way to describe the sensation is hazy, blurry and sometimes double vision.

Residual moderate pain and tenderness at deltoid site with tingling and radiation down to left arm. 3 weeks post injection.

Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.

1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heightens, slight chills, more fatigue 7pm ear itch both sides, all ear involved even lobe and red 9pm soreness, chills, arm pain 1/15 Friday 7:30am nausea, dizziness, sinus pressure, headache, arm pain 1pm extreme fatigue, sleep for afternoon, arm pain 4pm headache intensify, arm pain 6pm both ear swelling, warmth, extreme itch 9pm lingering headache, arm pain improves 1/16 Saturday 7am ear itch and rash spread to back of neck 12pm telehealth - recommended benadryl, Rx prednisone Benadryl ineffective, rash remains 8pm- itch inside ears, red scaly ears, hot after washing, extremely scaly 1/17 Sunday 6 pills of methyl prednisone Hives moved to back of neck following the back of ear 1/18 Monday 6pills prednisone inside ear itch, ear lobes itch, skin very flaky 1/19 Tuesday Go to urgent care 6pills prednisone 1/21 Thursday Rash spreads to collarbone Go to TMC Dermatology prednisone continued 1/24 Sunday Stopped steroid under recommendation of MD Huge flare up around neck, chest, back and down to lower body Itch continues to night, lack of sleep 1/27 Wednesday Placed back on steroid (16 day course) Rash remains, itch subsided Decision to not take second dose

1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness

Once patient in waiting room, after a few minutes, patient verbalized feelings of dizziness after receiving Vaccine in L arm. Given apple juice. Transferred via wheeled chair to private holding/monitoring room. Patient transferred onto gurnee. Pt began to complain of pain and feelings of heaviness in Left arm, given more juice and crackers to eat. Verbalized dizziness occurred with first dose, but one day after receiving. Patient states mild pain began at bridge of nose as dizziness begun. VS at 1845: BP of 126/82 in R arm. Heart rate 83bpm, Pulse ox 97%. HOB lowered to 45 degrees per pt request. At 1900, pulse ox 97%. Heart rate 77; B/P 120/80. Verbalizes lesser feelings of dizziness now, but still present.. At 1915 pulse ox 97%. heart rate 73bpm. B/P 126/80. Pt sat up to 90 degrees. Verbalizes tingling remains L arm. at 1920 patient able to stand up without dizziness, ambulate, and only c/o L arm soreness now. Ambulated in hallway twice before sending home. Patient stated she was Covid+ in October 2021

Upon receiving my first shot, I felt weak, and after a few days a tingly feeling in my head. Symptoms lasted for 2 weeks. After receiving the second dose, I had a fever that evening and weakness, it lasted through the next day. My right arm was sore for 2 days. I took Advil, Tylenol, and ibuprofen (at different times). Symptoms of fever lasted two days and were gone, I was left feeling weak, it lasted for a day. Now day 5 after I got my shot (got the last dose 1/22/2021), I have noticed some vaginal bleeding that has been going on for 2 days now (It's not the menstrual period since I had that going on a week before I got my last shot). I am wondering if there are any other women who have experienced the same reaction to their body. Kindly feel free to call me or email me with any answers. I am trying to reach my primary physician who is currently booked till February.

Migraine started 2.5 hours after receiving shot (2nd dose). Intense migraine with nausea, hand and facial tingling/ numbness, seeing spots. Went away at just about 24 hours after it started. Got the chills just before it went away, no fever. Skin sensitivity and fever set in around 26 hours in - 102. Heart rate jumped from 130-170. Improved to about 150 with Tylenol and ALOT of fluids as fever improved, remained high until fever was gone around noon the next day. Hip pain, neck pain and back pain throughout. Hip pain first 24 hours. Back pain following that.

Swollen lymph node to right axillary; Swollen lymph node to right axillary. Pain radiates to right breast, down right arm and around to the back and right scapula area/ tender to touch; Pain radiates to right breast; Pain radiates to right breast, down right arm; Pain radiates to right breast, down right arm and around to the back; Pain radiates to right breast, down right arm and around to the back and right scapula area; Pain caused inability to do daily activities; This is a spontaneous report from a contactable nurse (patient). A 29-years-old female patient ( received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 12Jan2021 07:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient had allergies to sulfamethoxazole, trimethoprim (BACTRIM), amoxicillin. The historical vaccine included the first dose of BNT162B2 at right arm on 21Dec2020 07:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node to right axillary, pain radiates to right breast, down right arm and around to the back and right scapula area, pain caused inability to do daily activities and area was tender to touch from 13Jan2021 02:00. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the batch number has been requested.

Within 5 minutes of receiving Covid Vaccine (Pfizer ), second dose..... Employee complains of difficulty breathing, warm, sweaty, left arm pain, lips swelling, tachycardia (p=140-100). Team called and sent to ER.

1week after second shot started experiencing facial nerve pain. No medical history of any pain before. Negative etiology from dentist. Received 5 day course of prednisone 50mg daily which resolved pain, however 1 day after finishing course pain returned. Worse at night with bouts of pain every 30 minutes when trying to sleep. Received steroids and carbamazepine from internal medicine doctor but this has not helped for this episode. Max doses of Tylenol and ibuprofen have not helped this episode.

Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature was 103.5F when I checked it at 12:30am. I removed clothing and put ice on my neck, and took tylenol and the fever came down to 102.5F in 30 min. I had a moderate headache, felt lightheaded and a little disoriented, and nauseous. The following morning and the entire next day I had a moderate to severe headache, malaise, nausea, and a low grade temp 99-99.8F.

Hives developed on the injection arm and spread across her chest; intense heart palpitations; weakness/dizziness; weakness/dizziness; This is a spontaneous report from a contactable Nurse (patient). A 29-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 07Jan2021 13:00 at SINGLE DOSE for COVID 19 vaccination. The patient was not pregnant. Medical history included Shellfish allergy. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 on 17Dec2020 07:00 AM at left arm for COVID 19 vaccination. On 07Jan2021, hives developed on the injection arm and spread across her chest within 5 minutes of receiving the vaccine, along with intense heart palpitations and weakness/dizziness. Resolved spontaneously after 10 minutes without any use of epinephrine or other medications. Oral diphenhydramine was taken afterwards. Treatment drug oral diphenhydramine received for events. The outcome of the events was recovered in Jan2021. No covid prior vaccination, no covid test post vaccination. Information on the lot/batch number has been requested.

Swollen neck, chills, body aches, arm pain. Took benadryl and felt better. Took one tylonal felt much better. Drinking hot tea seems to help with the swollen neck. The symptoms started about 4 hours after injection.

The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it was on fire. I had a rash on the opposite arm that i had the injection. I took benadryl to help with the rash in the morning and at night. That night i was freezing and i woke up in a sweat. This morning i woke up and the rash looks worse.

raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.

"Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan. 20th, 2021. On Jan. 21st, 2021, I woke up feeling feverish. I went to use the bathroom, and after washing my hands I walked towards the bathroom door and felt light-headed and dizzy. Suddenly, I passed out and hit my head and upper neck on the tile floor. My parents heard the sound of my fall and luckily rushed to the bathroom. They found me lying unconscious on the floor with my eyes rolled up for what felt like more than a minute. I regained consciousness on my own, and I drank water with a bit of sugar and salt mixed in. I felt too weak to get up and walk, and the back of my head and upper neck were in pain. I told my parents to call 911 as I wanted to make sure that there was no serious damage to my brain or neck area. I went to the local hospital in an ambulance. I was taken to the emergency room: Vitals were done and my temperature ranged from then was 99.5-101F and my heart rate was high- it stayed around 112 bpm for some time I was given 2 L of IV Saline Fluids EKG result: no clinical abnormalities CT head/neck/spine: negative 2 different types of COVID-19 tests: results were both negative Bloodwork: CBC/BMP/D-dimer: no clinical abnormalities Chest Xray: negative 2D- doppler ultrasound: negative Holter monitor: negative for irregular heart rhythm I was discharged the same day around 4:30pm

Constant stomach pains with a continuous loop of constipation and diarrhea. High levels of pain through the left arm and around the injection site.

Fever, rigors, severe nausea, headache, generalized weakness, body and joint aches. These lasted 10 hours. Total 4 days of significant fatigue, joint aches, neck stiffness.

First vaccine I had slight fever/ chills. Second vaccine on 01/27/21 I woke up next day with extreme body aches and a temp of 101.1. Going into today 01/31/21, I still have elevated temp been taking Ibuprofen and Tylenol but now having dizziness, left facial pressure/pain, and nausea with neck stiffness.

Immunization Admin. COVID-19 30mcg/0.3mL Dosage 1st Dose Pfizer (Z23); ­COVID-19 Vaccine, 30 Mcg/0.3mL Dosage, Diluent Reconstituted, For Intramuscular (Z23) (IM injection) Manufacturer Pfizer Lot EL3249 Expiring 05/01/2021 ­ Vaccination received on 1-12-21, left deltoid. She had localized stinging in left proximal lateral arm for first 12-24 hrs; then itchy welt at injection site and nearby separate itchy small area on proximal lateral arm on 1-13-21. Progressive increase in size/persistent itching. Evaluated on 1-19-21. Afebrile. There is 2x2.5 cm mildly tender, slightly indurated nodularity surrounded by 10x9 cm confluent erythema demarcated by pen, which has extended to 12x9.5 cm in widest margins. Confluent erythema is slightly warm to touch, nontender, nonindurated, no red streaks. No left axillary adenopathy. Treated with antihistamines.

Fever, Chills, severe Headache, fatigue, weakness, nausea, vomiting, back pain, mouth ulcers, UTI, body aches, muscle pain, dizziness, etc.

The lady?s technique was to put needle in with one hand. Switched the hand she was holding the needle with, then plunged the vaccine into my arm. I could feel the needle moving in my arm. It has been sore since!

Within 5 minutes after the vaccination I felt really dizzy and took had to take a couple deep breaths to calm down which went away pretty quickly. Almost immediatly afte,r I got a sharp shooting inside nerve pain from shoulder under the armpit area down to my wrist area. The pain was bad and constant until 1/14, aleve, ibuprophen or tylenol made it better. On 1/10-1/11 the pain was the worst and woke me up from sleeping it hurt so bad with a pain level of a 8/10. The pain was more nerve pain over muscle pain and the intensity never changed whether I moved or not.

Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection. Received vaccine at 9:15 AM. She initially felt well, but about 20-30 minutes after administration began to feel dizzy. Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration. Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx. However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain. By 11:08 no longer had symptoms except for arm pain. By 11:43 still feeling back to normal except for arm pain.

Body ache; Headache; blood pressure was 140/100; left leg swell; severe pain in toes; feel feverish; Chills; Warm body; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 11:00 at single dose for covid-19 immunization. Medical history included asthma. Concomitant medication included salbutamol sulfate (PROVENTIL) for asthma. Patient previously took first dose of bnt162b2 on 30Dec2020 at single dose for covid-19 immunization. Patient got second vaccination on 18Jan2021 and may be around about 11 O'clock on same day patient felt to have a body ache all over which patient knew it was normal. However, it was getting worse throughout the day. And patient couldn't even get up and went to work. Also have very bad headache and patient blood pressure was 140/100. For about 3 hours patient did had left leg swell and caused severe pain in toes, that just subsided. Patient didn't have a fever but patient feel feverish, chills, warm body. Patient had been taking Ibuprofen on and off as treatment. Outcome of events left leg swell and caused severe pain in toes were recovering, and outcome of other events was unknown. Information about Lot/Batch number is requested.

PT had Covid Pfizer vaccine on 02/01/21 at 8:47 am with no adverse reactions. While working at her desk at 11:40 am, (employee) patient states had gradual bilateral arms and bilateral legs shaking and back went into spasms. No loss of consciousness. PT walked to vaccination pod where seen by MD Resident and then take to ED for further exam

Received 2nd Covid vaccine dose on 01/31/21 at 07:13 AM. The evening after/bedtime after injection - Had severe chills, mild fever (highest temp 100.3F), myalgias/body aches, and aching/pain and burning in collar bone area. 02/01/21 at 04:00AM - still having above plus even more discomfort over collar bone (especially left side) noticed lump over left collar bone which was an enlarged left supraclavicular lymph node which was also very tender. 02/01/21 - called my primary physician, notified them of the above info and Appt scheduled for 2:00PM. Went to Appt for physician evaluation on 02/01/21 at 2:00PM. Follow-up Appt scheduled with Primary Physician for Thursday 02/04/21. Today 02/02/21 - lymph node remains enlarged and tender. Fever chills and body aches have subsided for now. Having headache today as well.

Site: Pain at Injection Site-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Other- Light-headed, numbness ONLY in lower hand and wrist-Medium

fever; chills; headache; bad body aches; continuous migraine; developed bad body sweats; This is a spontaneous report from a contactable Other HCP reporting for herself. A 29-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number eL0142), intramuscular on 05Jan2021 10:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 29 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) intramuscular administered on 16Dec2020 at 03:00 PM at single dose in right arm. Medical history included hypothyroidism, polycystic ovarian syndrome, low vitamin D from Apr2020, was diagnosed with COVID19 in Apr2020. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone, ergocalciferol (VIT D) birthcontrol pill. On 16Jan2021 at 03:00 PM, all of a sudden developed fever, chills, headache and bad body aches out of nowhere. Fever continued to progress despite Tylenol. Went to the hospital she worked at, and was COVID (Nasal Swab) and respiratory panel tested same night as symptom development at 11pm. Both have since come back negative. The fever and symptoms lasted for another 24 hours and the patient also developed bad body sweats even after fever had been broken. She had no other symptoms like congestion or sore throat that would signify another cause of the fever and symptoms, and ears and throat where checked at the hospital. The headache she had was similar to the headache when she had covid back in Apr2020. The headache was icepick like along with a continuous migraine. The only thing she did differently was the day before symptom onset, she did a pretty high intensity cardio workout for an hour. The events resulted in emergency room/department or urgent care and were resolving. No treatment was given other than Tylenol for fever.

moderate L arm pain; intermittent mild moderate retro orbital and tension headache; intermittent mild moderate retro orbital and tension headache; Difficulty sleeping with multiple awaking; Difficulty sleeping with multiple awaking; This is a spontaneous report from a contactable Physician (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284 and expiration date: 30Apr2021), intramuscular in left deltoid on 08Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included Menorrhagia. Concomitant medication included ongoing Mirena IUD from 04Jun2020 ('Once placed last 5 yr') for pregnancy prevention and menorrhagia. On 08Jan2021 (at PM), the patient developed moderate left (L) arm pain which improved gradually and resolved 10Jan2021 (at AM), significantly less severe than prior. Patient had intermittent mild moderate retro orbital and tension headache occurred 08Jan2021 (at PM) thru 10Jan2021 (at AM). Patient had difficulty sleeping with multiple awaking on 08Jan2021 to 09Jan2021 overnight. The patient was not admitted to the hospital. The reporter reported a reasonable possibility that the events were related to suspect product. No treatment was required. The outcome of the events moderate left (L) arm pain and retro orbital and tension headache was recovered on 10Jan2021; event difficulty sleeping with multiple awaking was recovered on 09Jan2021.

Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 195/110 ) leg pain, muscle aches

HAd trembling, heart racing, chest tingling some difficulty swallowing and swelling of the tongue. She premedicated with benadryl.

Arm soreness; pregnant at the time of vaccination (gestational period: 20 weeks); pregnant at the time of vaccination (gestational period: 20 weeks); pregnant at the time of vaccination (gestational period: 20 weeks); This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1681), via intramuscular route of administration on 18Jan2021 at 12:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies to penicillin. Concomitant medications included prenatal vitamins and cetirizine hydrochloride (ZYRTEC).The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that patient was pregnant at the time of vaccination (gestational period: 20 weeks). On an unspecified date, the patient experienced arm soreness but did not receive any treatment for the event. The event arm soreness was considered non-serious. The last menstrual date was reported as 28Aug2020. The mother was due to deliver on 04Jun2021. The patient underwent lab tests and procedures which included nasal swab test and PCR on 18Jan2021 and both were negative. The outcome of the event arm soreness was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Cramping/soreness in upper legs and buttocks, headache, mild sore throat, lethargy. Symptoms started just shy of 24 hours after the second injection and lasted the rest of the day. Symptoms resolved by morning the following day (2 days after vaccine).

Left half of face (same side as injection) from chin/neck to scalp was numb for approximately 8 hours. Felt very similar to the numbness of after dental work. Did NOT have face paralysis like that of Bell's Palsy just face numbness. After approximately 8 hours feeling was restored. As of 2+ weeks later no lasting effects.

PMH: dx with Grave's disease in 2014, s/p thyroidectomy 2/2 thyroid cancer on 8/10/2020 (now on synthroid 150 mcg). 1/26 ED VISIT: P/w chest pain/SOB went to ED. Patient received the COVID vaccination 3 days prior (1/23). Was in NSH the morning of vaccine, then in the afternoon became tired. Then developed a H/A (frontal and right sided, that has resolved) and chills. p/w SS chest pain, radiating to the right shoulder and to the back. Worsened with deep inspiration and difficult to take a deep breath. Took tylenol at 8 pm yesterday (1/25) and advil at 1 pm yesterday (1/25). A/w DOE. Denies birth control use, n/v, abd pain, urinary symptoms, tobacco/etoh/drug use, recent travel, cough, le swelling, hx pe/dvt. Patient had imagining completed - no significant findings and discharged on percocet and ibuprofen. Patient represented to the ED on 2/2/2021: Over the last two days, patient has tender right shoulder pain radiating to neck and chest with ROM and strength limited by pain associated with nausea. Evaluate for rhabdo and myocarditis - negative. Patient seen by ortho (note unable to be obtained). 2/4 Telehealth visit: The patient reports still having a swollen lymph node under her left axillary area. She denies fever. Patient reports pain to her right shoulder. She presented to ortho who said it might be an infected cyst and attempted to drain it unsuccessfully. Patient mentions pain and tingling to her left breast. She notes right shoulder pain to the back of her neck that radiates down to her left arm. She notes a stabbing back pain and rib pain when she takes a deep breath. Patient given levofloxacin and gabapentin

After the vaccine was administered, 5-10 minutes later I began to feel a rapid heart rate. One of the nurses came to check on me, I described to her my symptoms, and she let me know if they get worse to inform her. In the next 5 minutes, my head began to hurt, as well as, some chest pain. She checked on me again, and said to let her know if things got worse. Within the next 5-10 minutes after, I had difficulty swallowing and speaking. I raised my hand, and the nurse came over, then proceeded to get help. They then took my blood pressure and heart rate. My blood pressure was 185/103 and I believe my pulse was 156 bpm. I was still having a hard time swallowing and speaking. They proceeded to get an epi pen and the doctor on site, as well as suggested to send me over the ER/ call 911. The doctor checked my lungs, and they noticed my blood pressure and heart rate was not decreasing to a normal level. I was then put in a wheel chair and transferred to the ER. At the ER, my blood pressure and heart rate was still elevated, as well as difficulty swallowing. The doctor ordered Benadryl via IV, steroids, and the epi pen. After having a reaction to the Benadryl, the epi pen was put on hold. After about 15 minutes, I began to feel better. I was put on IV fluids and observation. I was able to leave the ER around 12 pm 2/05/21. At this time, 7:22 pm, I am feeling better with mild muscle aches, and fatigue.

Patient arrived to vaccine clinic for her 1st Pfizer vaccine. She received her vaccine at 1606. She was then walked out to the waiting room to wait her 15-20 minutes that is strongly recommended after receiving the vaccine. Approximately 5 minutes later, she alerted the reception staff that she was having some sort of reaction. I was then notified immediately and patient was brought back to a private exam area. Patient complained of chest tightness, numbness in fingers and a racing heartbeat. She also felt that she was having difficulty breathing. Vital signs at that time were 96.3 temperature, RR 36, blood pressure 170/100 and a heart rate of 174. Patient received (1) epipen and 911 was simultaneously notified. 2 liters of oxygen via nasal cannula were applied. Shortly after epipen was given and oxygen applied, patients heartrate decreased into the 130s. Oxygen remained stable at 99-100% on 2 liters nasal cannula. Ice pack applied to base of neck for comfort. EMS arrived and report given as patient will be taken to the emergency department for further evaluation.

15 hours after receiving the 2nd dose of the Pfizer vaccine, I woke up at 1:00 am with severe chills, shakes, body aches and my left arm (injection arm) could hardly lift up. I had water that night. In the morning, about 5 hours after these symptoms (6:30 am), I had a pounding headache and still body aches. I took Tylenol every 5-6 hours. About 3pm, the only symptom I still had was a headache which was mild-mod. By the next morning, I felt back to normal.

felt flushed; This is a spontaneous report from a contactable Nurse. A 29-year-old female patient received the first dose of of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247 with Expiration Date 31May2021), on 18Jan2021 (at 08:30) at 0.3 ml single dose on the left deltoid for COVID-19 immunisation. No relevant medical history was provided. The patient did not have relevant concomitant medications. She was vaccinated at COVID vaccine center where they are administering the Pfizer vaccine. On 18Jan2021 (at 09:05), she felt flushed. She took cetirizine hydrochloride (ZIRTEC) at home in preparation; she was given juice and cookies. At 9:20, patient was feeling better, she was monitored for 30 more minutes in observation area and stated she was feeling fine and left. The patient had recovered from the events on 18Jan2021.

29F no PMH had COVID-19 almost 1 year ago. On 2/2 received 1st shot of COVID-19 vaccine. Since then with mild headache, body aches, chill. On the morning of 2/3, with prolonged standin, felt weak, abdominal pain, pre-syncopal, grabbed a co-worker and then syncopized. Caught and did not sustain injuries. Rapid response called and she was brought here.

Vial had been removed from deep freezer to cooler for longer period of time than recommended by Pfizer. By time realized, vaccine had been administered to patient (employee). Pharmacy contacted Pfizer and Infection Disease MDs for counsel. Said wouldn't hurt patient, however not able to guarantee effect; stated could offer 3rd dose in 3-4 weeks. Notified Employee; stated did experience expected side effects of fatigue, chilling, body aches and possibly fever (didn't check) and declined 3rd vaccination offer

Adverse event: Blurred vision, numbness left side head to shoulder, vomiting, chills, shortness of breath, severe headache, oral mycosis swelling Treatment: Benadryl Outcome: Sent to ER by facility MD, treated and observed at hospital for 1.5 hours released no negative outcome

After second shot had numbness on the left side of face approximately ten minutes after shot, was less numbness than shot one. Approximately 3 hours after shot developed hives on same area of face that was number. Hives last about 2 hours and cleared up with OTC Benadryl. Face numbness stopped about 6.5 hours after injection

Approximately 4 minutes after receiving my vaccine I felt warmth down injected arm. Approximately 20 minutes post injection, I experienced a drop in my blood pressure, heaviness in my legs (like walking through cement), and ringing in my ears. At approximately 12:30-12:45pm I experienced mental fog (I couldn't remember how to turn off my windshield wipers), increased heart rate, rapid onset of feelings of panic, minor shortness of breath, neck/clavicle tightness on side of injection, and sweating. Between approximately 1:30pm and 2:30pm I continued to have extreme sweating, as well as: increased pulse, fatigue, dry throat, muscle weakness/shakiness, brain fog, and headache. At approximately 3:30 I hit my knee on the bed frame and felt like the wind had been knocked out of me and immediately had a severe drop in blood pressure that felt similar to a vasovagal event. I called the vaccine clinic and my symptoms were noted and I was told to seek help if my symptoms worsened or I felt like I was going to pass out. My symptoms have not worsened but I am still experiencing extreme sweating along with shivering, shakiness, blood pressure changes with movement (orthostatic hypotension), and fatigue - time is currently 5:50pm

Morning of 14th, I woke up and my left arm hurt to move - it wasn't the site itself, it was under my armpit (where the lymph node is). I didn't call my doctor at that point because I read that it was a side effect. Dull/always there pain at that point. On the 15th, shooting pains - this lasted two days. It started getting better again by the 17th. It was resolved by the 18th. 14-17th - Swelling that I could feel and see and that also went back to normal by the 18th. It was just tender to touch for a little while after that....after it didn't hurt to move I didn't pay as much attention to it. I was able to go to work but I had to modify what I could do at work. I could not do my normal swimming exercise until that next week.

anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.

Left second toe became discolored and stinging/painful, then left 4th toe. Exam c/w pernio/chillblains

the arm i received the injection felt like it was on fire; The opposite arm had a rash on it; I was freezing at night and i woke up in a sweat; I was freezing at night and i woke up in a sweat; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old. Lot number was EL9262. Medical history was none. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old (lot number was EL3248). Concomitant medications included desogestrel, ethinylestradiol (ISIBLOOM) for birth control, ESCITALOPRAM OXALATE (LEXAPRO), vitamin D. On 28Jan2021 at 07:45, the patient woke up and the arm where she received the injection felt like it was on fire; the opposite arm had a rash on it; the patient took benadryl that morning and at night after she got home from work. On 28Jan2021, the patient was freezing at night and he woke up in a sweat. On 29Jan2021, the rash looks worse. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.

PFIZER-BIONTECH COVID-19 . Individual had nausea/vomiting, fever 101.6, fatigue and body aches x 48 hours following first dose on 1/20/21. After second dose of vaccine, reported: itching, stridor, cough, nausea, vomiting, dizziness, tachycardia, acute change in mental status, temp102.5, DBP >100, tremors for 48 hours. Did not see doctor or other healthcare provider.

Difficulty breathing- received EpiPen dose, patient was able to breath normally again Shortly thereafter patient was witnessed to have seizure like activity, EMS was called and administered Ativan and Benadryl in route to ED